Early treatment with fluvoxamine, bromhexine, cyproheptadine, and niclosamide to prevent clinical deterioration in patients with symptomatic COVID-19: a randomized clinical trial.

Background: Repurposed drugs with host-directed antiviral and immunomodulatory properties have shown promise in the treatment of COVID-19, but few trials have studied combinations of these agents. The aim of this trial was to assess the effectiveness of affordable, widely available, repurposed drugs used in combination for treatment of COVID-19, which may be particularly relevant to low-resource countries. Methods: We conducted an open-label, randomized, outpatient, controlled trial in Thailand from October 1, 2021, to June 21, 2022, to assess whether early treatment within 48-h of symptoms onset with combinations of fluvoxamine, bromhexine, cyproheptadine, and niclosamide, given to adults with confirmed mild SARS-CoV-2 infection, can prevent 28-day clinical deterioration compared to standard care. Participants were randomly assigned to receive treatment with fluvoxamine alone, fluvoxamine + bromhexine, fluvoxamine + cyproheptadine, niclosamide + bromhexine, or standard care. The primary outcome measured was clinical deterioration within 9, 14, or 28 days using a 6-point ordinal scale. This trial is registered with ClinicalTrials.gov (NCT05087381). Findings: Among 1900 recruited, a total of 995 participants completed the trial. No participants had clinical deterioration by day 9, 14, or 28 days among those treated with fluvoxamine plus bromhexine (0%), fluvoxamine plus cyproheptadine (0%), or niclosamide plus bromhexine (0%). Nine participants (5.6%) in the fluvoxamine arm had clinical deterioration by day 28, requiring low-flow oxygen. In contrast, most standard care arm participants had clinical deterioration by 9, 14, and 28 days. By day 9, 32.7% (110) of patients in the standard care arm had been hospitalized without requiring supplemental oxygen but needing ongoing medical care. By day 28, this percentage increased to 37.5% (21). Additionally, 20.8% (70) of patients in the standard care arm required low-flow oxygen by day 9, and 12.5% (16) needed non-invasive or mechanical ventilation by day 28. All treated groups significantly differed from the standard care group by days 9, 14, and 28 (p < 0.0001). Also, by day 28, the three 2-drug treatments were significantly better than the fluvoxamine arm (p < 0.0001). No deaths occurred in any study group. Compared to standard care, participants treated with the combination agents had significantly decreased viral loads as early as day 3 of treatment (p < 0.0001), decreased levels of serum cytokines interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1 beta (IL-1ß) as early as day 5 of treatment, and interleukin-8 (IL-8) by day 7 of treatment (p < 0.0001) and lower incidence of post-acute sequelae of COVID-19 (PASC) symptoms (p < 0.0001). 23 serious adverse events occurred in the standard care arm, while only 1 serious adverse event was reported in the fluvoxamine arm, and zero serious adverse events occurred in the other arms. Interpretation: Early treatment with these combinations among outpatients diagnosed with COVID-19 was associated with lower likelihood of clinical deterioration, and with significant and rapid reduction in the viral load and serum cytokines, and with lower burden of PASC symptoms. When started very soon after symptom onset, these repurposed drugs have high potential to prevent clinical deterioration and death in vaccinated and unvaccinated COVID-19 patients. Funding: Ped Thai Su Phai (Thai Ducks Fighting Danger) social giver group.

Diagnostic Value of the Bispectral Index to Assess Sleep Quality after Elective Surgery in Intensive Care Unit.

Purpose: Monitoring and improving sleep quality may help recovery from major illness. Polysomnography is a gold standard for measuring sleep quality, but routine use is not practical. The goal of this study is to investigate the diagnostic accuracy of an alternative monitor, the Bispectral Index (BIS), for evaluating the quality of sleep-in postoperative patients in the intensive care unit (ICU). Study design: An observational study. Materials and methods: Patients admitted to postoperative ICU after elective major noncardiac surgery were monitored with both BIS and PSG during the first night. The temporally synchronized data from both monitors were obtained for measurement of the association. Clinical outcomes were compared between patients with different postoperative sleep quality. Results: Thirty-three patients were enrolled in this study. For determining the average BIS index associated with good postoperative sleep quality, receiver operating characteristics (ROC) curve was generated. Area under the ROC curve (AUC) was 0.65. The cutoff with best discriminability was 75 with a sensitivity of 68% and a specificity of 56%. Compared with those with good and poor postoperative sleep quality, there were no differences in main postoperative outcomes including duration of mechanical ventilation and ICU stay. Although the quality of sleep after surgery of all subjects with postoperative delirium was poor, the incidence of delirium between the groups did not significantly differ (0% vs 10.3%; p = 0.184). Conclusion: The monitoring of BIS is a viable tool for evaluating sleep quality in mechanically ventilated patients in the postoperative ICU with acceptable precision. Trial registration: www.clinicaltrials.in.th, TCTR20200310005. How to cite this article: Sirilaksanamanon P, Thawitsri T, Charuluxananan S, Chirakalwasan N. Diagnostic Value of the Bispectral Index to Assess Sleep Quality after Elective Surgery in Intensive Care Unit. Indian J Crit Care Med 2023;27(11):795-800.

Perioperative temperature management: a survey of 6 Asia-Pacific countries.

BACKGROUND: Anesthesia leads to impairments in central and peripheral thermoregulatory responses. Inadvertent perioperative hypothermia is hence a common perioperative complication, and is associated with coagulopathy, increased surgical site infection, delayed drug metabolism, prolonged recovery, and shivering. However, surveys across the world have shown poor compliance to perioperative temperature management guidelines. Therefore, we evaluated the prevalent practices and attitudes to perioperative temperature management in the Asia-Pacific region, and determined the individual and institutional factors that lead to noncompliance. METHODS: A 40-question anonymous online questionnaire was distributed to anesthesiologists and anesthesia trainees in six countries in the Asia-Pacific (Singapore, Malaysia, Philippines, Thailand, India and South Korea). Participants were polled about their current practices in patient warming and temperature measurement across the preoperative, intraoperative and postoperative periods. Questions were also asked regarding various individual and environmental barriers to compliance. RESULTS: In total, 1154 valid survey responses were obtained and analyzed. 279 (24.2%) of respondents prewarm, 508 (44.0%) perform intraoperative active warming, and 486 (42.1%) perform postoperative active warming in the majority of patients. Additionally, 531 (46.0%) measure temperature preoperatively, 767 (67.5%) measure temperature intraoperatively during general anesthesia, and 953 (82.6%) measure temperature postoperatively in the majority of patients. The availability of active warming devices in the operating room (p < 0.001, OR 10.040), absence of financial restriction (p < 0.001, OR 2.817), presence of hospital training courses (p = 0.011, OR 1.428), and presence of a hospital SOP (p < 0.001, OR 1.926) were significantly associated with compliance to intraoperative active warming. CONCLUSIONS: Compliance to international perioperative temperature management guidelines in Asia-Pacific remains poor, especially in small hospitals. Barriers to compliance were limited temperature management equipment, lack of locally-relevant standard operating procedures and training. This may inform international guideline committees on the needs of developing countries, or spur local anesthesiology societies to publish their own national guidelines.

The Effectiveness of Intravenous Parecoxib on the Incidence of Ipsilateral Shoulder Pain After Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVES: To determine the incidence of ipsilateral shoulder pain (ISP) with the therapeutic use of parecoxib compared with a placebo after thoracotomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled trial. SETTING: A tertiary-care university hospital. PARTICIPANTS: Adult patients undergoing an elective thoracotomy between June 2011 and February 2015. INTERVENTIONS: Patients were allocated randomly into the parecoxib group (n = 80) and the control group (n = 80). In the parecoxib group, 40 mg of parecoxib was diluted into 2 mL and given intravenously 30 minutes before surgery and then every 12 hours postoperatively for 48 hours. In the control group, 2 mL of normal saline was given to the patients at the same intervals. MEASUREMENTS AND MAIN RESULTS: A numerical rating scale was used to assess the intensity of ISP at 2, 6, 12, 24, 48, 72, and 96 hours after surgery. Intravenous morphine (0.05 mg/kg) was used as the rescue medication for ISP during the 96-hour period. Baseline characteristics of patients in both groups were comparable. Patients in the parecoxib group had a significantly lower incidence of ISP, both overall (42.5% v 62.0%, p = 0.014) and of moderate-to-severe ISP when compared with the control group (26.2% v 49.4%, p = 0.003). Parecoxib reduced the risk of ISP by a statistically significant 32% (risk ratio, 0.68; 95% confidence interval, 0.50-0.93, p = 0.016). There were no significant differences in the occurrence of adverse effects between the groups. CONCLUSIONS: Intravenous parecoxib significantly can reduce the incidence and severity of ISP after thoracotomy.

Noradrenaline, Serotonin, GABA, and Glycine in Cerebrospinal Fluid during Labor Pain: A Cross-Sectional Prospective Study.

BACKGROUND AND AIMS: The inhibitory pathways that play a role in spinal modulation include local interneurons and descending control. Clinical data regarding the role of these pathways in acute pain is lacking. Accordingly, the aim of this study was to evaluate cerebrospinal fluid (CSF) levels of noradrenaline, serotonin, gamma-aminobutyric acid (GABA), and glycine in parturients with labor pain compared to those without labor pain. METHODS: One hundred term uncomplicated pregnant women receiving spinal anesthesia for cesarean section were enrolled in this prospective cross-sectional study. CSF noradrenaline, serotonin, GABA, and glycine levels were analyzed by enzyme-linked immunosorbent assay. Labor pain score was assessed by numerical rating scale. RESULTS: Median CSF serotonin concentration in parturients with labor pain was significantly lower than in those without pain (p < 0.001). Median CSF glycine level in the labor pain group was significantly higher than in the control group (p < 0.001). There were no significant differences in median CSF level of noradrenaline or GABA between parturients with and without labor pain. Subsequent analysis showed labor pain scores to be negatively correlated with CSF serotonin (r = -0.217, p = 0.04) but positively correlated with CSF glycine (r = 0.415, p < 0.001). CONCLUSION: CSF serotonin and glycine were significantly correlated with labor pain scores. These findings suggest that the serotonergic and glycinergic systems may play a role in spinal modulation of visceral pain.

Safety of Phenylephrine in Antihypotensive Treatment during Spinal Anesthesia for Cesarean Section.

OBJECTIVE: In Thailand, hypotension after spinal anesthesia for cesarean section is routinely treated by ephedrine. As incidence of fetal acidosis reportedly increases resulting from placental transfer of ephedrine, phenylephrine, an alpha-1 agonist with less lipid solubility, becomes an alternative. However, the potential development of serious bradycardia after phenylephrine is a concern. The objectives of this study were to investigate the incidence of serious bradycardia and identify risk factors associated with phenylephrine-induced serious bradycardia and other side effects of phenylephrine. MATERIAL AND METHOD: This descriptive cross-sectional study was conducted between July 1, 2014 and March 15, 2015 on 509 parturients undergoing cesarean section under spinal anesthesia. Predelivery hypotension was treated by intravenous phenylephrine 100 mcg and pretherapeutic heart rate (pHR) was recorded. If serious bradycardia (HR < 60 bpm and hypotension or HR <45 bpm) developed, atropine 0.6 mg was administered intravenously. Data were analyzed using multivariable logistic regression and AuROC. RESULTS: Incidence of serious bradycardia was 11% (95% CI: 8.0-14.0). A one bpm increment increase in pHR reduced this incidence by 4% (adjusted OR: 0.96; 95% CI: 0.94-0.98, p < 0.001; AuROC: 0.76). As compared to apHR greater than 80 bpm, apHR of 61 to 80 bpm and a pHR of 60 bpm or lower increased the risk of serious bradycardia by 3.55 times and 12.81 times, respectively. Other risk factors were height (adjusted OR: 0.94; 95% CI: 0.89-0.98, p = 0.015), baseline DBP (adjusted OR: 0.97; 95% CI: 0.94-0.99,p = 0.03), and anesthetic level at first minute (adjusted OR: 1.13; 95% CI: 1.02-1.23, p = 0.02). Benign and temporary abnormal ECG readings were noted. CONCLUSION: Phenylephrine for antihypotensive treatment in spinal anesthesia induces bradycardia. Findings indicate an association between slower HR at time phenylephrine is administered and serious bradycardia. Close ECG monitoring and prompt treatment are required.

Self-Reporting of Medication Errors in Critically Ill Surgical Patients in the THAI-SICU Study.

Objective: The objective of this study was to collect the data of medication errors by the self-report of doctors and nurses in critically ill surgical patients. Material and Method: All data were collected from THAI-SICU database in nine medical schools in Thailand during a period of 22 months. The occurrence and medication error related factors were recorded. Results: From 4,652 admissions, there were only 10 cases of medication error. Of these, there were only 7 cases of complete self-report medication error, and all of them had no critical side effects. Most cases were of receiving wrong doses of medicine especially overdosing. The medicine preparers, administrators and the error detectors were mostly nurses. For immediate outcomes, two cases were reported of low blood pressure and one case was reported of lowering self-conscious. For longterm outcomes, there were two cases of prolonged ICU stays. Regarding the contributing factors, the most frequent problem found was communication. The most important factor minimizing incidents was to increase proper care. As to suggested corrective strategies, it was found that improved supervision was most needed. Conclusion: Reporting of medication errors by a self-report of doctors and nurses is low in this cohort, which might result from occurrences not being reported. The wrong dose is the most common occurrence and the communication is the most related factor.

Treatment with Vasoactive Drugs and Outcomes in Surgical Critically Ill Patients: The Results from the THAI-SICU Study.

Objective: The purpose of this study is to assess the impact of the use of vasoactive drugs on morbidity and mortality in surgical critically ill patients. Material and Method: We conducted a multi-center prospective observational study in Thai university-based surgical intensive care units (SICU) over a 22-month period. Patient data were recorded by case record form in 3 main phases: admission, daily and discharge. Data collection included patient characteristics, pattern of vasoactive drugs use, and outcomes. Results: Nine university-based SICU comprising 4,652 patients were included in the study. The vasopressor exposed patient group had 1,155 patients (24.8%). Either vasopressor or inotrope exposed group demonstrated significantly higher ICU mortality, 28-day mortality and new arrhythmia than the non-exposed group (p<0.001). In multivariable analysis, norepinephrine or epinephrine significantly increased risks of all unfavorable outcomes while dopamine significantly increased only new arrhythmia (OR 1.44; 95% CI 1.02-2.02, p = 0.036) in vasopressor-exposed patients. Epinephrine had the highest risk of all unfavorable outcomes with an OR 3.17; 95% CI 2.10-4.78, (p<0.001) for ICU mortality, OR 2.62; 95% CI 1.73-3.97, (p<0.001) for 28-day mortality, and OR of 1.77; 95% CI 1.13-2.75, (p = 0.012) for new arrhythmia. Neither dobutamine nor milrinone showed any significant results in inotrope exposed patients. Conclusion: Vasoactive drug exposed patient groups had significantly higher incidence of new arrhythmia, ICU mortality, and 28-day mortality. Epinephrine exposure was associated with the highest risk of unfavorable outcomes. Further information from well-designed studies is needed to justify the most appropriate use of vasoactive drugs.

Lactate Non-Clearance versus Lactate Clearance: A Comparison of Hospital Mortality in High-Risk Surgical Patients.

Objective: The optimal endpoints of resuscitation in high-risk surgical patients remain controversial. Specifically, it is difficult to establish the effective predictive markers as the endpoints of resuscitation in this patient group. Therefore, the study was conducted to assess the predictive value of early lactate non-clearance condition on hospital mortality in high-risk surgical patients. Material and Method: The study is a prospective analytic study. The data were collected in one university-based surgical intensive care unit (SICU) over a 5-month period. All consecutive adult high-risk surgical patients admitted to SICU in postoperative period were recruited to the study. Blood lactate levels were measured on SICU admission (0-hour), 12 hours later, and then calculated for 12-hour blood lactate clearance. The authors categorized the patients into two groups: lactate clearance (LC) and lactate non-clearance (LNC). After that, the patients were monitored until hospital discharge or inhospital death. Results: There were 122 high-risk surgical patients recruited to the study. As concerns the factors of interest, higher incidences of suspected or confirmed infection and mechanical ventilation were found among the LNC group. Regarding the main outcomes, hospital mortality was 5.3% among the LNC group and 3.9% among the LC group (p = 0.578), with no statistical significant differences in hospital mortality, hospital length of stay and SICU length of stay. The independent risk factors associated with LNC condition were considered. The factor of interest was suspected or confirmed infection by multiple logistic regression analysis after adjustment for age and sex revealed that the adjusted odds ratio was 2.70 with a 95% confidence interval of 0.85-8.55, p = 0.092. Conclusion: In high-risk surgical patients, 12-hour LNC cannot demonstrate the prognostic value for hospital morbidity and mortality. However, there is a trend for the suspected or confirmed infection group to associate with the LNC condition, but with no statistical significance.

Randomized cinefluoroscopic comparison of cervical spine motion using McGrath series 5 and Macintosh laryngoscope for intubation with manual in-line stabilization.

BACKGROUND: Intubation in patients with suspected cervical spine injury must be cautiously performed to avoid any further neurologic trauma. Several intubation techniques have been introduced to minimize cervical spine motion such as the use of the videolaryngoscope. OBJECTIVE: The present study aims to compare the movement of the cervical spine during intubation by using McGrath series 5 videolaryngoscope (MGL) and that of the conventional Macintosh laryngoscope from cinefluoroscopic imaging. MATERIAL AND METHOD: Twenty-two patients undergoing elective orthopedic surgery that did not involve cervical spine procedure and required general anesthesia were recruited into the study. All patients were randomized either to have intubation with MGL (n = 11) or Macintosh laryngoscope (n = 11) in a neutral position with manual in-line stabilization (MILS). The primary outcome was the cervical vertebral angle changes pre- and post-intubation, measured by cinefluoroscopy. The number of intubation attempts, the laryngoscopic view, the time to intubation, and the incidence ofany complications were recorded as well. RESULTS: Eleven patients were included in each group without any exclusion from the study. The cervical vertebral angle changes pre- and post-intubation with the MGL was less than with the Macintosh laryngoscope at C3/4 (2.00 vs. 4.27 degrees, respectively; p-value = 0.034) and the cumulative changes of all cervical spine levels (9.18 vs. 17.18 degrees, respectively; p-value = 0.017). However, the time to intubation with the MGL was longer (35.07 vs. 23.21 seconds, p-value = 0.004), the laryngoscope view was better. There were no statistically significant differences in the intubation success rate, the number of attempts, and the incidence of complications. CONCLUSION: Orotracheal intubation with MGL provided less cervical spine motion and improved visualization of the vocal cords, without causing adverse consequences as compared with Macintosh laryngoscope and MILS.

Prognostic factors for death and survival with or without complications in cardiac arrest patients receiving CPR within 24 hours of anesthesia for emergency surgery.

PURPOSE: To determine prognostic factors for death and survival with or without complications in cardiac arrest patients who received cardiopulmonary resuscitation (CPR) within 24 hours of receiving anesthesia for emergency surgery. PATIENTS AND METHODS: A retrospective cohort study approved by the Maharaj Nakorn Chiang Mai University Hospital Ethical Committee. Data used were taken from records of 751 cardiac arrest patients who received their first CPR within 24 hours of anesthesia for emergency surgery between January 1, 2003 and October 31, 2011. The reviewed data included patient characteristics, surgical procedures, American Society of Anesthesiologist (ASA) physical status classification, anesthesia information, the timing of cardiac arrest, CPR details, and outcomes at 24 hours after CPR. Univariate and polytomous logistic regression analyses were used to determine prognostic factors associated with the outcome variable. P-values of less than 0.05 were considered statistically significant. RESULTS: The outcomes at 24 hours were death (638/751, 85.0%), survival with complications (73/751, 9.7%), and survival without complications (40/751, 5.3%). The prognostic factors associated with death were: age between 13-34 years (OR =3.08, 95% CI =1.03-9.19); ASA physical status three and higher (OR =6.60, 95% CI =2.17-20.13); precardiopulmonary comorbidity (OR =3.28, 95% CI =1.09-9.90); the condition of patients who were on mechanical ventilation prior to receiving anesthesia (OR =4.11, 95% CI =1.17-14.38); surgery in the upper abdominal site (OR =14.64, 95% CI =2.83-75.82); shock prior to cardiac arrest (OR =6.24, 95% CI =2.53-15.36); nonshockable electrocardiography (EKG) rhythm (OR =5.67, 95% CI =1.93-16.62); cardiac arrest occurring in postoperative period (OR =7.35, 95% CI =2.89-18.74); and duration of CPR more than 30 minutes (OR =4.32, 95% CI =1.39-13.45). The prognostic factors associated with survival with complications were being greater than or equal to 65 years of age (OR =4.30, 95% CI =1.13-16.42), upper abdominal site of surgery (OR =10.86, 95% CI =1.99-59.13), shock prior to cardiac arrest (OR =3.62, 95% CI =1.30-10.12), arrhythmia prior to cardiac arrest (OR =4.61, 95% CI =1.01-21.13), and cardiac arrest occurring in the postoperative period (OR =3.63, 95% CI =1.31-10.02). CONCLUSION: The mortality and morbidity in patients who received anesthesia for emergency surgery within 24 hours of their first CPR were high, and were associated with identifiable patient comorbidity, age, shock, anatomic site of operation, the timing of cardiac arrest, EKG rhythm, and the duration of CPR. EKG monitoring helps to identify cardiac arrest quickly and diagnose the EKG rhythm as a shockable or nonshockable rhythm, with CPR being performed as per the American Heart Association (AHA) CPR Guidelines 2010. The use of the fast track system in combination with an interdisciplinary team for surgery, CPR, and postoperative care helps to rescue patients in a short time.

Incidence of and factors associated with perioperative cardiac arrest within 24 hours of anesthesia for emergency surgery.

PURPOSE: To determine the incidence of and factors associated with perioperative cardiac arrest within 24 hours of receiving anesthesia for emergency surgery. PATIENTS AND METHODS: This retrospective cohort study was approved by the ethical committee of Maharaj Nakorn Chiang Mai Hospital, Thailand. We reviewed the data of 44,339 patients receiving anesthesia for emergency surgery during the period from January 1, 2003 to March 31, 2011. The data included patient characteristics, surgical procedures, American Society of Anesthesiologists (ASA) physical status classification, anesthesia information, location of anesthesia performed, and outcomes. Data of patients who had received topical anesthesia or monitoring anesthesia care were excluded. Factors associated with cardiac arrest were identified by univariate analyses. Multiple regressions for the risk ratio (RR) and 95% confidence intervals (CI) were used to determine the strength of factors associated with cardiac arrest. A forward stepwise algorithm was chosen at a P-value <0.05. RESULTS: The incidence (within 24 hours) of perioperative cardiac arrest in patients receiving anesthesia for emergency surgery was 163 per 10,000. Factors associated with 24-hour perioperative cardiac arrest in emergency surgery were age of 2 years or younger (RR =1.46, CI =1.03-2.08, P=0.036), ASA physical status classification of 3-4 (RR =5.84, CI =4.20-8.12, P<0.001) and 5-6 (RR =33.98, CI =23.09-49.98, P<0.001), the anatomic site of surgery (upper intra-abdominal, RR =2.67, CI =2.14-3.33, P<0.001; intracranial, RR =1.74, CI =1.35-2.25, P<0.001; intrathoracic, RR =2.35, CI =1.70-3.24, P<0.001; cardiac, RR =3.61, CI =2.60-4.99, P<0.001; and major vascular; RR =3.05, CI =2.22-4.18, P<0.001), respiratory or cardiovascular comorbidities (RR =1.95, CI =1.60-2.38, P<0.001 and RR =1.38, CI =1.11-1.72, P=0.004, respectively), and patients in shock prior to receiving anesthesia (RR =2.62, CI =2.07-3.33, P<0.001). CONCLUSION: The perioperative incidence of cardiac arrest within 24 hours of anesthesia for emergency surgery was high and associated with multiple factors such as young age (≤2 years old), cardiovascular and respiratory comorbidities, increasing ASA physical status classification, preoperative shock, and surgery site. Perioperative care providers, including surgeons, anesthesiologists, and nurses, should be prepared to manage promptly this high risk group of surgical patients.

Incidence of and risk factors for cardiovascular complications after thoracic surgery for noncancerous lesions.

OBJECTIVE: The purpose of this study was to determine the incidence of and risk factors for cardiovascular complications after thoracic surgery for noncancerous lesions. DESIGN: Retrospective cohort study. SETTING: A tertiary medical center. PARTICIPANTS: All consecutive patients undergoing either thoracotomy or thoracoscopy for noncancerous lesions between 2005 and 2011 were included. MEASUREMENTS AND MAIN RESULTS: The primary outcomes were the incidence and types of cardiovascular complications such as cardiac arrhythmias, cardiac arrest, heart failure, and myocardial ischemia during hospitalization. A total of 719 patients were recruited, 60% of whom had infections. The incidence of cardiovascular complications after thoracic surgery was 6.7% (48 of 719), of which cardiac arrhythmia was the most common (25 of 48, 52%). The multivariate risk regression analysis showed that age>55 years (risk ratio [RR]=4.0; 95% confidence interval [CI]=2.1-7.5; p<0.01), diabetes mellitus (RR=3.0; 95% CI=1.7-5.3; p<0.01), coronary artery disease (RR=4.8; 95% CI=2.3-10.2; p<0.01), duration of surgery>180 minutes (RR=2.6; 95% CI=1.3-5.1; p<0.01), intraoperative hypotension (RR=2.6; 95% CI=1.6-4.3; p<0.01), and positive fluid balance>2,000 mL (RR=2.5; 95% CI=1.4-4.5; p<0.01) were independent risk factors for cardiovascular complications. CONCLUSIONS: Knowledge of risk factors could help surgical teams to identify high risk patients and adjust modifiable risk factors including optimization of medical conditions, correction of intraoperative hypotension, and appropriate blood and fluid administration in order to reduce perioperative morbidity and mortality.

Association of positive fluid balance and cardiovascular complications after thoracotomy for noncancer lesions.

OBJECTIVE: The purpose of this study was to explore the influence of positive fluid balance on cardiovascular complications after thoracotomy for noncancer lesions. METHODS: After approval from an institutional review board, a retrospective cohort study was conducted. All consecutive patients undergoing thoracotomy between January 1, 2005 and December 31, 2011 in a single medical center were recruited. The primary outcome of the study was the incidence of cardiovascular complications, which were defined as cardiac arrhythmia, cardiac arrest, heart failure, myocardial ischemia, and pulmonary embolism. Univariable and multivariable risk regression analyses were used to evaluate the association between positive fluid balance and cardiovascular complications. RESULTS: A total of 720 patients were included in this study. The incidence of cardiovascular complications after thoracotomy for noncancer lesions was 6.7% (48 of 720). Patients with positive fluid balance >2,000 mL had a significantly higher incidence of cardiovascular complications than those with positive fluid balance ≤2,000 mL (22.2% versus 7.0%, P=0.005). Cardiac arrhythmias were the most common complication. Univariable risk regression showed that positive fluid balance >2,000 mL was a significant risk factor (risk ratio =3.15, 95% confident interval [CI] =1.44-6.90, P-value =0.004). After adjustment for all potential confounding variables during multivariable risk regression analysis, positive fluid balance >2,000 mL remained a strong risk factor for cardiovascular complications (risk ratio =2.18, 95% CI =1.36-3.51, P-value =0.001). Causes of positive fluid balance >2,000 mL included excessive hemorrhage (48%), hypotension without excessive hemorrhage (29.6%), and liberal fluid administration (22.4%). CONCLUSION: Positive fluid balance was a significant risk factor for cardiovascular complications. Strategies to minimize positive fluid balance during surgery for patients at high risk of cardiovascular complications include preparing adequate blood and blood products, considering appropriate hemoglobin level as a transfusion trigger, and adjusting the optimal dose of local anesthetic for intraoperative thoracic epidural analgesia.

Development of an open-heart intraoperative risk scoring model for predicting a prolonged intensive care unit stay.

BACKGROUND: Based on a pilot study with 34 patients, applying the modified sequential organ failure assessment (SOFA) score intraoperatively could predict a prolonged ICU stay, albeit with only 4 risk factors. Our objective was to develop a practicable intraoperative model for predicting prolonged ICU stay which included more relevant risk factors. METHODS: An extensive literature review identified 6 other intraoperative risk factors affecting prolonged ICU stay. Another 168 patients were then recruited for whom all 10 risk factors were extracted and analyzed by logistic regression to form the new prognostic model. RESULTS: The multivariate logistic regression analysis retained only 6 significant risk factors in the model: age ≥ 60 years, PaO2/FiO2 ratio ≤ 200 mmHg, platelet count ≤ 120,000/mm(3), requirement for inotrope/vasopressor ≥ 2 drugs, serum potassium ≤ 3.2 mEq/L, and atrial fibrillation grading ≥ 2. This model was then simplified into the Open-Heart Intraoperative Risk (OHIR) score, comprising the same 6 risk factors for a total score of 7-a score of ≥ 3 indicating a likely prolonged ICU stay (AUC for ROC of 0.746). CONCLUSIONS: We developed a new, easy to calculate OHIR scoring system for predicting prolonged ICU stay as early as 3 hours after CPB. It comprises 6 risk factors, 5 of which can be manipulated intraoperatively.

The initial success rate of cardiopulmonary resuscitation and its associated factors in patients with cardiac arrest within 24 hours after anesthesia for an emergency surgery.

PURPOSE: To determine the initial success rate and its associated factors on cardiopulmonary resuscitation (CPR) in patients with cardiac arrest within 24 hours after receiving anesthesia for an emergency surgery. PATIENTS AND METHODS: After the hospital ethical committee gave approval for this study, the anesthesia providers recorded all relevant data regarding CPR in patients with cardiac arrest within 24 hours after anesthesia for emergency surgery at Maharaj Nakorn Chiang Mai Hospital, a university hospital in Northern Thailand. Only data from the cardiac arrest patients who received the first CPR attempt were included in the analysis. The end point of the initial success of CPR was return of spontaneous circulation (ROSC). Factors related to ROSC were determined by univariate analyses and multiple logistic regression analysis. The odds ratios (OR) and 95% confidence intervals (CI) were used to calculate the strength of the factors associated with the ROSC. RESULTS: Of the 96 cardiac arrest patients, 44 patients (45.8%) achieved ROSC. Factors associated with ROSC were electrocardiogram monitoring for detected cardiac arrest (OR =4.03; 95% CI =1.16-14.01; P=0.029), non-shock patients before arrest (OR =8.54; 95% CI =2.13-34.32; P=0.003), timing to response of activated CPR team within 1 minute (OR =9.37; 95% CI =2.55-34.39; P<0.001), having trained CPR teams (OR =8.76; 95% CI =2.50-30.72; P<0.001), and administration of more than one dose of epinephrine (OR =5.62; 95% CI =1.32-23.88; P<0.019). CONCLUSION: Patients undergoing anesthesia for an emergency surgery are at risk for perioperative cardiac arrest with high mortality which requires immediate CPR. Our results have confirmed that early detection of cardiac arrest by vigilant electrocardiogram monitoring and prompt management with a qualified team are important factors in improving the success of CPR. Emergency surgical patients at risk for cardiac arrest should be promptly managed, with facilities available not only during the operation but also during the pre- to postoperative period.

A randomized, double-blind, placebo-controlled trial of oral pregabalin for relief of shoulder pain after laparoscopic gynecologic surgery.

STUDY OBJECTIVE: To investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING: Tertiary referral center, university hospital. PATIENTS: Fifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013. INTERVENTIONS: Women in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses, and women in the control group received an identical capsule and the same dosage of placebo. MEASUREMENTS AND MAIN RESULTS: Visual analog scale (VAS) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome. Postoperative analgesics used and drug-related adverse events were also monitored. Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours, compared with the placebo group (median, 23.14 [range, 13.67-32.61] vs. 37.22 [27.75-46.64]; p = .04), and required less analgesic (p = .01). There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups (p = .56). CONCLUSIONS: Perioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used.

The effect of prophylactic dexmedetomidine on hemodynamic disturbances to double-lumen endotracheal intubation: a prospective, randomized, double-blind, and placebo-controlled trial.

The purpose of this study was to determine the effect of dexmedetomidine on hemodynamic responses to DLT intubation compared to placebo and to assess the adverse effects related to dexmedetomidine. Sixty patients were randomly allocated to receive 0.7 µ g/kg dexmedetomidine (n = 30) or normal saline (n = 30) 10 minutes before general anesthesia. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and rate pressure product (RPP) between groups were recorded. During intubation and 10 minutes afterward (T1-T10), the mean SBP, DBP, MAP, HR, and RPP in the control group were significantly higher than those in the dexmedetomidine group throughout the study period except at T1. The mean differences of SBP, DBP, MAP, HR, and RPP were significantly higher in the control group, with the value of 15.2 mmHg, 10.5 mmHg, 14 mmHg, 10.5 beats per minute, and 2,462.8 mmHg min(-1). Four patients in the dexmedetomidine group and 1 patient in the control group developed hypotension, while 2 patients in the dexmedetomidine group had bradycardia. Prophylactic dexmedetomidine can attenuate the hemodynamic responses to laryngoscopy and DLT intubation with minimal adverse effects. This trial is registered with ClinicalTrials.gov NCT01289769.

WITHDRAWN: Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery.

BACKGROUND: There are two common techniques for postoperative pain control after intra-abdominal surgery: patient-controlled analgesia (PCA) with intravenous opioids and continuous epidural analgesia (CEA). It is uncertain which method has better pain control and fewer adverse effects. OBJECTIVES: The objective of this review was to compare PCA opioid therapy with CEA for pain control after intra-abdominal surgery in terms of analgesic efficacy, side effects, patient satisfaction and surgical outcome by meta-analysis of the relevant trials. SEARCH METHODS: We searched CENTRAL (The Cochrane Library Issue 4, 2002), MEDLINE (January 1966 to October 2002), EMBASE (January 1988 to October 2002), and reference lists of articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomized controlled trials of adult patients after intra-abdominal surgery comparing the effect of two pain control regimens in terms of analgesic efficacy and side effects. In the patient-controlled analgesia (PCA) group the patient should be able to operate the device himself. In the continuous epidural analgesia group there was no PCA device. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: Nine studies involving 711 participants were included. The PCA group had a higher pain visual analogue scale than the CEA group during 6, 24 and 72 hour periods. The weighted mean difference and 95% confidence interval of resting pain was 1.74 (95% CI 1.30 to 2.19), 0.99 (95% CI 0.65 to 1.33), and 0.63 (95% CI 0.24 to 1.01), respectively. The length of hospital stay and other adverse effects were not statistically different except that the incidence of pruritus was lower in the PCA group, odds ratio of 0.27 (95% CI 0.11 to 0.64). AUTHORS' CONCLUSIONS: CEA is superior to opioid PCA in relieving postoperative pain for up to 72 hours in patients undergoing intra-abdominal surgery, but it is associated with a higher incidence of pruritus. There is insufficient evidence to draw comparisons about the other advantages and disadvantages of these two methods of pain relief.