[Short-term deep sedation strategy in patients with spontaneous intracerebral hemorrhage: a randomized controlled trial].

OBJECTIVE: To evaluate the efficacy and safety of short-term deep sedation strategy in patients with spontaneous intracerebral hemorrhage (ICH) after surgery. METHODS: A perspective, randomized, parallel-group study was conducted. Adult patients with spontaneous ICH and undergoing craniotomy admitted to Daxing Teaching Hospital of Capital Medical University from December 2015 to November 2016 were enrolled. The patients who received surgery were randomly divided into a short-term deep sedation and a slight and middle sedation group. Sufentanil was used as an analgesic drug in all patients and midazolam was used as a sedative after the operation. The patients in the slight and middle sedation group received midazolam 0.05-0.10 mg/kg with a goal of mild sedation [Richmond agitation and sedation scale (RASS) score of -2-1]. The patients in the short-term deep sedation group received midazolam 0.1-0.2 mg/kg with a goal of deep sedation (RASS score of -4 to -3) and a duration of no more than 12 hours. Postoperative sedation, blood pressure changes, laboratory indexes, residual hematoma and clinical outcomes were recorded in two groups. RESULTS: During the study, a total of 183 patients with spontaneous ICH were collected, excluding who was older than 65 years, with shock, and with preoperative Glasgow coma score (GCS) of 3. 106 patients were enrolled in this study, and 53 patients were assigned to the short-term deep sedation group and slight and middle sedation group, respectively. In the slight and middle sedation group, 4 patients received reoperation because of repeated hemorrhage and no patient operated repeatedly in the short-term deep sedation group, and there was a significant difference between the two groups (χ 2 = 4.000, P = 0.045). The number of patients undergoing tracheotomy in the short-term deep sedation group was significantly lower than that in the slight and middle sedation group (9 cases vs. 21 cases, P < 0.05). RASS score within 12 hours after operation of the patients in the short-term deep sedation group was lower than that in slight and middle sedation group [-4 (-4, -2) vs. -2 (-3, -1) at 4 hours, -4 (-4, -2) vs. -1 (-2, 0) at 8 hours, -3 (-4, -2) vs. 0 (-2, 1) at 12 hours, all P < 0.01], sudden restlessness was significantly reduced [times: 1 (0, 1) vs. 3 (2, 3), P < 0.01], and postoperative sedation duration was significantly prolonged [hours: 14.0 (8.3, 20.8) vs. 8.9 (3.4, 15.3), P < 0.05]. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) within 12 hours after operation in the short-term deep sedation group were significantly lower than those of the slight and middle sedation group [SBP (mmHg, 1 mmHg = 0.133 kPa): 136.8±30.5 vs. 149.1±33.5, DBP (mmHg): 85.0 (70.8, 102.3) vs. 89.0 (69.2, 116.7), both P < 0.05]. There were no significant differences in the arterial blood gas, routine blood test or coagulation function between the two groups at 24 hours after operation. The volume of residual hematoma at 2, 7 and 14 days after operation in the short-term deep sedation group was significantly decreased as compared with slight and middle sedation group (mL: 16.4±15.6 vs. 38.2±22.2 at 2 days, 9.6±8.7 vs. 20.6±18.6 at 7 days, 1.2±1.0 vs. 4.4±3.6 at 14 days, all P < 0.05), number of deaths in 3 months were significantly less (5 cases vs. 13 cases), and the patients with favorable prognosis were increased significantly (39 cases vs. 12 cases, both P < 0.05). CONCLUSIONS: The study results showed that short-term deep sedation strategy after surgery can reduce the incidence of adverse events and improve the prognosis of patients with spontaneous ICH, so it is safe and effective.

Bispectral Index Can Reliably Detect Deep Sedation in Mechanically Ventilated Patients: A Prospective Multicenter Validation Study.

BACKGROUND: Excessively deep sedation is prevalent in mechanically ventilated patients and often considered suboptimal. We hypothesized that the bispectral index (BIS), a quantified electroencephalogram instrument, would accurately detect deep levels of sedation. METHODS: We prospectively enrolled 90 critically ill mechanically ventilated patients who were receiving sedation. The BIS was monitored for 24 hours and compared with the Richmond Agitation Sedation Scale (RASS) evaluated every 4 hours. Deep sedation was defined as a RASS of -3 to -5. Threshold values of baseline BIS (the lowest value before RASS assessment) and stimulated BIS (the highest value after standardized assessment) for detecting deep sedation were determined in a training set (45 patients, 262 RASS assessments). Diagnostic accuracy was then analyzed in a validation set (45 patients, 264 RASS assessments). RESULTS: Deep sedation was only prescribed in 6 (6.7%) patients, but 76 patients (84.4%) had at least 1 episode of deep sedation. Thresholds for detecting deep sedation of 50 for baseline and 80 for stimulated BIS were identified, with respective areas under the receiver-operating characteristic curve of 0.771 (95% confidence interval, 0.714-0.828) and 0.805 (0.752-0.857). The sensitivity and specificity of baseline BIS were 94.0% and 66.5% and of stimulated BIS were 91.0% and 66.5%. When baseline and stimulated BIS were combined, the sensitivity, specificity, and clinical utility index were 85.0% (76.1%-91.1%), 85.9% (79.5%-90.7%), and 66.9% (57.8%-76.0%), respectively. CONCLUSIONS: Combining baseline and stimulated BIS may help detect deep sedation in mechanically ventilated patients.

Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study.

INTRODUCTION: Emergence agitation after intracranial surgery is an important clinical issue during anaesthesia recovery. The aim of this multicentre cohort study is to investigate the incidence of emergence agitation, identify the risk factors and determine clinical outcomes in adult patients after intracranial surgery under general anaesthesia. Additionally, we will deliberately clarify the relationship between postoperative pneumocephalus and agitation. METHODS AND ANALYSIS: The present study is a prospective multicentre cohort study. Five intensive care units (ICUs) in China will participate in the study. Consecutive adult patients admitted to the ICUs after intracranial surgery will be enrolled. Sedation-Agitation Scale (SAS) or Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the patients 12 h after the enrolment. Agitation is defined as an SAS score of 5-7, or an RASS score of +2 to +4. According to the maximal SAS and RASS score, patients will be divided into two cohorts: the agitation group and the non-agitation group. Factors potentially related to emergence agitation will be collected at study entry, during anaesthesia and operation, during postoperative care. Univariate analyses between the agitation and the non-agitation groups will be performed. The stepwise backward logistic regression will be carried out to identify the independent predictors of agitation. Patients will be followed up for 72 h after the operation. Accidental self-extubation of the endotracheal tube and removal of other catheters will be documented. The use of sedatives and analgesics will be collected. ETHICS AND DISSEMINATION: Ethics approval has been obtained from each of five participating hospitals. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02318199.

[Efficacy and safety of early rapid infusion of icy normal saline in patients after cardiopulmonary resuscitation].

OBJECTIVE: To assess the feasibility, safety, and effectiveness of early rapid icy normal saline infusion to attain mild hypothermia in cardiac arrest patients. METHODS: A single-center prospective randomized controlled trial was conducted. From March 2011 to October 2013, patients who had recovery of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR) in Beijing Daxing District People's Hospital were randomly divided into two groups. In icy normal saline group, patients received a rapid infusion of 1 000 mL of 4 centigrade normal saline intravenously to attain a mild hypothermia. In the control group, the patients were treated with ice bag on head, and axillary temperature was monitored. For all patients, rectal temperature was measured and recorded immediately and 1 hour later. The occurrence of pulmonary edema on initial chest X-ray at 6 hours, occurrence of tremor within 48 hours, ventricular fibrillation recurring within 48 hours, and consciousness or death within 14 days were recorded. RESULTS: A total of 45 patients were enrolled, including 23 patients in icy normal saline group and 22 in control group. The patients in icy normal saline group had a rectal temperature descended from (36.7 ± 0.9) centigrade to (34.9 ± 0.7) centigrade 1 hour later, while the patients in control group had a rectal temperature risen from (36.5 ± 1.0) centigrade to (37.9 ± 0.9) centigrade 1 hour later. There was significant difference in rectal temperature between two groups (t=2.228, P=0.031). The number of patients who successfully awaken within 14 days in ice normal saline group was significantly larger than that in control group (13 cases vs. 7 cases, χ² = 65.710, P=0.021). There was no statistical difference in the occurrence of acute pulmonary edema (4 cases vs. 6 cases), tremor (2 cases vs. 0 case), ventricular fibrillation recurrence (4 cases vs. 5 cases) and death within 14 days(11 cases vs. 12 cases, all P>0.05). CONCLUSIONS: The study shows that early rapid i.v. infusion of 4 centigrade normal saline is feasible, safe and effective for cerebral resuscitation.

A novel surgical procedure: scaffold-pulmonary autograft transplantation.

Mitral valve-related operations are easy to perform and show good results, but to prevent severe thromboembolism or a high ratio of prosthetic valve destruction by tissue, lifetime anticoagulant therapy is essential after the operation. Thus, identifying a new type of surgical procedure and prosthetic valve to cure mitral valve diseases is necessary. Pulmonary valve autograft transplantation (Ross II) with the "top hat" transplantation technique was first reported by Ross DN to cure mitral disease. Because the "top hat" procedure has some shortcomings, we designed the scaffold-pulmonary autograft transplantation procedure and performed animal experiments to confirm the feasibility and effectiveness of the procedure. A total of 13 minipigs, weighing 20-25 kg, were employed as experimental animals to undergo scaffold-pulmonary autograft valve transplantation in our surgical animal lab. The surgical procedure was performed under hypothermic general anaesthesia and extracorporeal circulation (or cardiopulmonary bypass, CPB). Briefly, the chest cave was opened through the left intercostal, the pulmonary valve autograft was harvested during on-pump beating heart, and the pulmonary valve autograft was mounted in a self-made pulmonary valve scaffold and transferred to the mitral valve annulus without removing the mitral instruments. Finally, the outflow tract of the right ventricle was re-established with a pig pulmonary homograft. After finishing data collection, all animals were executed 1 hour after removal from the CPB. For the 13 minipigs that underwent the operation, the CPB time was 182.4 ± 23.4 min. Two of the thirteen cases died of bleeding during the operation and of a post-operative pulmonary embolism, and the remaining eleven survived for one hour. The pressure of the left atrium did not increase significantly (P = 1.00), and the ultrasonic cardiograph (UCG) showed good function of the new mitral valves, with mean ejection fraction (EF) values of 63.6%. The mitral valve orifice areas were 1.10 ± 0.13 cm(2) (pre-operation) and 1.01 ± 0.08 cm(2) (post-operation) (P = 0.013). The function and structure of the new mitral valves were normal. We preliminarily consider scaffold-pulmonary autograft valve transplantation to be a new alternative to cure mitral valve disease, but advanced chronic animal experiments will be needed to confirm the long-term results of the operation. The results showed it could be a new alternative to cure mitral valve disease.

Effect of pulmonary autograft transplantation in the surgical treatment of aortic valve disease.

BACKGROUND: Aortic root replacement with pulmonary autograft (Ross procedure) has the advantages of good haemodynamics and growth potential without the need for anticoagulation. In this study, we reviewed our experience of the Ross procedure for patients with aortic valve disease. METHODS: From October 1994 to January 2005, 42 Ross procedures were performed in our centre. There were 30 males and 12 females. The mean age was 28 +/- 15 years (range, 5-56 years). Congenital heart disease (CHD) with aortic valve stenosis (AS) and/or aortic valve insufficiency (AI) in 40 cases including one associated with ventricular septal defect (VSD), degenerated aortic valve disease with AS in 1 and subacutive bacterial endocarditis (SBE) with AI in 1 were studied. The diagnosis was made by ultracardiography (UCG) in all patients. The mean aortic valve annulus diameter (AVD) was (2.45 +/- 0.31) cm and pulmonary valve annulus diameter (MPVD) was (2.34 +/- 0.21) cm. All patients had normal pulmonary valves. The New York Heart Association (NYHA) function class was II in 36 cases and III in 6 cases. The operation was performed under moderate hypothermic cardiopulmonary bypass (CPB) with aortic root replacement using pulmonary autograft and pulmonary valve replacement with a homograft. RESULTS: There was no early hospital mortality. Postoperative UCG showed normal aortic valve function in all our patients. The mean gradient across the aortic valve was (6.11 +/- 0.12) mmHg. The left ventricular diastole diameter (LVDD) decreased significantly from (62 +/- 5) mm to (56 +/- 3) mm (P < 0.001). The mean postoperative left ventricular ejective fraction (LVEF) was 0.49 +/- 0.23. All patients were in NYHA class I-II. Follow-up was completed in 38 cases for a mean period of 3.2 years (range 1-10 years). All survivors were in NYHA class I with normal neo-aortic and pulmonary valve function. One patient died after secondary operation due to homograft fungal endocarditis 1 year after the Ross procedure. The cause of death was uncontrolled bleeding. Another patient suffered from cardiogenic shock and was on extracorporeal membrane oxygenation (ECMO) for 10 days postoperatively. This patient was subsequently self-discharged from hospital due to financial issues and he was excluded from follow-up. CONCLUSION: The Ross procedure is an excellent technique to treat aortic valve disease. Our data show that it can be performed safely with good early and mid-term clinical outcomes.