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1.
JAMA ; 321(23): 2292-2305, 2019 06 18.
Article in English | MEDLINE | ID: mdl-31157366

ABSTRACT

Importance: An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain. Objective: To determine whether a higher level of PEEP with alveolar recruitment maneuvers decreases postoperative pulmonary complications in obese patients undergoing surgery compared with a lower level of PEEP. Design, Setting, and Participants: Randomized clinical trial of 2013 adults with body mass indices of 35 or greater and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia. The trial was conducted at 77 sites in 23 countries from July 2014-February 2018; final follow-up: May 2018. Interventions: Patients were randomized to the high level of PEEP group (n = 989), consisting of a PEEP level of 12 cm H2O with alveolar recruitment maneuvers (a stepwise increase of tidal volume and eventually PEEP) or to the low level of PEEP group (n = 987), consisting of a PEEP level of 4 cm H2O. All patients received volume-controlled ventilation with a tidal volume of 7 mL/kg of predicted body weight. Main Outcomes and Measures: The primary outcome was a composite of pulmonary complications within the first 5 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonary infiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax. Among the 9 prespecified secondary outcomes, 3 were intraoperative complications, including hypoxemia (oxygen desaturation with Spo2 ≤92% for >1 minute). Results: Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, -2.3% [95% CI, -5.9% to 1.4%]; risk ratio, 0.93 [95% CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0% in the high level of PEEP group vs 13.6% in the low level of PEEP group; difference, -8.6% [95% CI, -11.1% to 6.1%]; P < .001). Conclusions and Relevance: Among obese patients undergoing surgery under general anesthesia, an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers, compared with a strategy with a lower level of PEEP, did not reduce postoperative pulmonary complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02148692.


Subject(s)
Intraoperative Care , Lung Diseases/prevention & control , Obesity/complications , Positive-Pressure Respiration/methods , Postoperative Complications/prevention & control , Surgical Procedures, Operative/adverse effects , Adult , Anesthesia, General , Body Mass Index , Female , Humans , Lung Diseases/etiology , Male , Middle Aged , Pleural Diseases/etiology , Pleural Diseases/prevention & control , Pulmonary Atelectasis/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/prevention & control , Tidal Volume , Treatment Outcome
2.
Br J Anaesth ; 122(3): 361-369, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30770054

ABSTRACT

BACKGROUND: The aim of this post hoc analysis of a large cohort study was to evaluate the association between night-time surgery and the occurrence of intraoperative adverse events (AEs) and postoperative pulmonary complications (PPCs). METHODS: LAS VEGAS (Local Assessment of Ventilatory Management During General Anesthesia for Surgery) was a prospective international 1-week study that enrolled adult patients undergoing surgical procedures with general anaesthesia and mechanical ventilation in 146 hospitals across 29 countries. Surgeries were defined as occurring during 'daytime' when induction of anaesthesia was between 8:00 AM and 7:59 PM, and as 'night-time' when induction was between 8:00 PM and 7:59 AM. RESULTS: Of 9861 included patients, 555 (5.6%) underwent surgery during night-time. The proportion of patients who developed intraoperative AEs was higher during night-time surgery in unmatched (43.6% vs 34.1%; P<0.001) and propensity-matched analyses (43.7% vs 36.8%; P=0.029). PPCs also occurred more often in patients who underwent night-time surgery (14% vs 10%; P=0.004) in an unmatched cohort analysis, although not in a propensity-matched analysis (13.8% vs 11.8%; P=0.39). In a multivariable regression model, including patient characteristics and types of surgery and anaesthesia, night-time surgery was independently associated with a higher incidence of intraoperative AEs (odds ratio: 1.44; 95% confidence interval: 1.09-1.90; P=0.01), but not with a higher incidence of PPCs (odds ratio: 1.32; 95% confidence interval: 0.89-1.90; P=0.15). CONCLUSIONS: Intraoperative adverse events and postoperative pulmonary complications occurred more often in patients undergoing night-time surgery. Imbalances in patients' clinical characteristics, types of surgery, and intraoperative management at night-time partially explained the higher incidence of postoperative pulmonary complications, but not the higher incidence of adverse events. CLINICAL TRIAL REGISTRATION: NCT01601223.


Subject(s)
After-Hours Care/statistics & numerical data , Intraoperative Complications/epidemiology , Lung Diseases/epidemiology , Postoperative Complications/epidemiology , Surgical Procedures, Operative , Adult , Aged , Cohort Studies , Female , Humans , Incidence , Internationality , Male , Middle Aged , Prospective Studies , Risk Factors
3.
Br J Anaesth ; 121(4): 899-908, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30236252

ABSTRACT

BACKGROUND: There is limited information concerning the current practice of intraoperative mechanical ventilation in obese patients, and the optimal ventilator settings for these patients are debated. We investigated intraoperative ventilation parameters and their associations with the development of postoperative pulmonary complications (PPCs) in obese patients. METHODS: We performed a secondary analysis of the international multicentre Local ASsessment of VEntilatory management during General Anesthesia for Surgery' (LAS VEGAS) study, restricted to obese patients, with a predefined composite outcome of PPCs as primary end-point. RESULTS: We analysed 2012 obese patients from 135 hospitals across 29 countries in Europe, North America, North Africa, and the Middle East. Tidal volume was 8.8 [25th-75th percentiles: 7.8-9.9] ml kg-1 predicted body weight, PEEP was 4 [1-5] cm H2O, and recruitment manoeuvres were performed in 7.7% of patients. PPCs occurred in 11.7% of patients and were independently associated with age (P<0.001), body mass index ≥40 kg m-2 (P=0.033), obstructive sleep apnoea (P=0.002), duration of anaesthesia (P<0.001), peak airway pressure (P<0.001), use of rescue recruitment manoeuvres (P<0.05) and routine recruitment manoeuvres performed by bag squeezing (P=0.021). PPCs were associated with an increased length of hospital stay (P<0.001). CONCLUSIONS: Obese patients are frequently ventilated with high tidal volume and low PEEP, and seldom receive recruitment manoeuvres. PPCs increase hospital stay, and are associated with preoperative conditions, duration of anaesthesia and intraoperative ventilation settings. Randomised trials are warranted to clarify the role of different ventilatory parameters in obese patients. CLINICAL TRIAL REGISTRATION: NCT01601223.


Subject(s)
Lung Diseases/etiology , Obesity/complications , Obesity/physiopathology , Postoperative Complications/etiology , Respiration, Artificial , Anesthesia, General , Body Mass Index , Body Weight , Humans , Kaplan-Meier Estimate , Length of Stay , Lung Diseases/epidemiology , Positive-Pressure Respiration , Postoperative Complications/epidemiology , Sleep Apnea Syndromes/complications , Tidal Volume
4.
Br J Anaesth ; 120(5): 1066-1079, 2018 May.
Article in English | MEDLINE | ID: mdl-29661384

ABSTRACT

BACKGROUND: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research. METHODS: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials. RESULTS: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition. CONCLUSIONS: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.


Subject(s)
Lung Diseases/diagnosis , Outcome Assessment, Health Care/methods , Perioperative Care/methods , Postoperative Complications/diagnosis , Research Design , Consensus , Humans , Randomized Controlled Trials as Topic , Reference Standards
7.
Trials ; 18(1): 202, 2017 04 28.
Article in English | MEDLINE | ID: mdl-28454590

ABSTRACT

BACKGROUND: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. METHODS/DESIGN: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. DISCUSSION: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.


Subject(s)
Anesthesia, General , Intraoperative Care/methods , Lung Diseases/prevention & control , Lung/physiopathology , Obesity/complications , Positive-Pressure Respiration/methods , Surgical Procedures, Operative , Anesthesia, General/adverse effects , Body Mass Index , Clinical Protocols , Female , Humans , Intraoperative Care/adverse effects , Lung Diseases/diagnosis , Lung Diseases/etiology , Lung Diseases/physiopathology , Male , Obesity/diagnosis , Obesity/physiopathology , Positive-Pressure Respiration/adverse effects , Protective Factors , Research Design , Risk Factors , Surgical Procedures, Operative/adverse effects , Time Factors , Treatment Outcome
9.
J Hazard Mater ; 326: 197-210, 2017 Mar 15.
Article in English | MEDLINE | ID: mdl-28027490

ABSTRACT

Magnesium alloys and graphite from spent nuclear fuel have been stored together in La Hague plant. The packaging of these wastes is under consideration. These wastes could be mixed in a grout composed of industrially available cement (Portland, calcium aluminate…). Within the alkaline pore solution of these matrixes, magnesium alloys are imperfectly protected by a layer of Brucite resulting in a slow corrosion releasing hydrogen. As the production of this gas must be considered for the storage safety, and the quality of wasteform, it is important to select a cement matrix capable of lowering the corrosion kinetics. Many types of calcium based cements have been tested and most of them have caused strong hydrogen production when magnesium alloys and graphite are conditioned together because of galvanic corrosion. Exceptions are binders based on alkali hydroxide activated ground granulated blast furnace slag (BFS) which are presented in this article.

10.
Encephale ; 41(5): 420-8, 2015 Oct.
Article in French | MEDLINE | ID: mdl-25979378

ABSTRACT

INTRODUCTION: In France, there are two main types of court-ordered treatment (COT) as far as mental health is concerned: obligations of treatment and injunctions of treatment. Obligations of treatment date back from 1958 whereas the law implementing injunctions of treatment is fairly recent as it was passed in 1998. Obligations and injunctions of treatment are two different types of COT that differ in terms of proceedings (obligations of treatment require no preliminary forensic psychiatric assessment; as for injunctions of treatment, they require the appointment of a coordinating medical doctor) and that are applied for different offences. However, both are psychiatric commitment procedures connecting the judicial, medical and social fields and their overall numbers have been on the rise. These common psychiatric practices have seldom been assessed and no review of the literature on the subject has ever been published. Better knowledge of such forensic practices is essential to their improvement and even to adjust the legal framework of these measures that are enjoying a boom. The purpose of this literature review is to define the prevalence of COT as well as the sociodemographic, criminal and psychiatric characteristics of those concerned by such measures. MATERIAL AND METHODS: A review of the French medical literature on COT was carried out using Science Direct up to December 2013. The results of seven studies were included and analysed. This was completed with a review of the articles listed in social sciences and law databases (Cairn and Dalloz). RESULTS: It has become increasingly frequent to rely on psychiatric teams to implement COT while at the same time public mental health services have to face a surge in activity with restricted financial means. Obligations of treatment are far more common (about 20,000 court orders a year) than injunctions of treatment (about 4000 measures are currently being enforced). However the latter have showed an increase of 506% over the 2000 decade. Both measures mainly concern men (83-99%) who are rather low on the social scale. In about half of these men, no mental disorder was found, however the prevalence of personality disorders ranged from 22 to 65% while that of psychotic disorders was low. Injunctions of treatment concerned sex offenders (90% of cases) whereas obligations of treatment concern non-sexual abusers (40-70%) rather than sex offenders (20-30%). DISCUSSION: Psychiatric research on COT is still thin on the ground and its methodology does not allow rigorous evaluation though the use of such measures is growing. When confronted with people who have not sought any care or treatment, healthcare professionals are at a loss. In France, training in forensic psychiatry is inadequate and specialised healthcare (particularly for sex offenders) need improving to reach the level of those found in many other European countries. The purpose of psychiatric treatment differs from that of lawmakers whose aim is to prevent recidivism. However, better treatment consistency requires setting up partnerships between justice, health and social services. To improve connections, there are various avenues of work such as, for instance, the creation of coordinating medical doctors for injunctions of treatment in France or European experiments using a multidisciplinary approach to prevent recidivism in sex offenders. The framework of such a partnership remains to be created as it is part and parcel of COT but has not been provided for in the law. Healthcare jurisdictions as defined in the 2009 French National Health Law might provide an appropriate framework for mental health and law professionals to collaborate.


Subject(s)
Commitment of Mentally Ill/legislation & jurisprudence , Commitment of Mentally Ill/statistics & numerical data , France , Humans , Mental Health Services , Prisoners , Psychiatry , Socioeconomic Factors
11.
Br J Anaesth ; 113(4): 644-51, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24928634

ABSTRACT

BACKGROUND: Chronic kidney disease is an independent predictor of perioperative cardiovascular morbidity and mortality. We analysed the preoperative estimated glomerular filtration rate (eGFR) as a risk factor for perioperative major adverse cardiovascular and cerebrovascular events (MACCE) in non-cardiac surgery. METHODS: In a post hoc analysis of the ANESCARDIOCAT database, patients were classified into six stages of eGFR calculated with the abbreviated Modification of Diet in Renal Disease Study and the Chronic Kidney Disease Epidemiology Collaboration equations: >90 (1), 60-89.9 (2), 45-59.9 (3a), 30-44.9 (3b), 15-29.9 (4), and <15 (5) ml min(-1) 1.73 m(-2). We analysed differences in MACCE, length of hospital stay, and all-cause mortality between eGFR stages. RESULTS: The eGFR was available in 2323 patients. Perioperative MACCE occurred in 4.5% of patients and cardiac-related mortality was 0.5%. Five hundred and forty-three (23.4%) patients had an eGFR of <60 ml min(-1) 1.73 m(-2) and 127 (5.4%) had an eGFR below 45 ml min(-1) 1.73 m(-2). Logistic regression analysis showed that MACCE increased with eGFR impairment (P<0.001), with a marked increase from stage 3b onwards (odds ratio 1.8 vs 3.9 in 3a and 3b, respectively, P=0.047). All-cause mortality was not related to eGFR (P=0.071), but increased substantially between stages 3b and 4. The length of stay correlated with eGFR (P<0.001). CONCLUSIONS: Perioperative MACCE increase with declining eGFR, primarily when <45 ml min(-1) 1.73 m(-2). We recommend the use of preoperative eGFR for cardiovascular risk assessment.


Subject(s)
Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cerebrovascular Disorders/epidemiology , Cerebrovascular Disorders/etiology , Glomerular Filtration Rate/physiology , Intraoperative Complications/epidemiology , Postoperative Complications/epidemiology , Adult , Aged , Databases, Factual , Female , Humans , Kidney Function Tests , Logistic Models , Male , Middle Aged , Odds Ratio , Preoperative Period , Prospective Studies , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/epidemiology , Risk Assessment , Sex Factors , Treatment Outcome
13.
Minerva Anestesiol ; 79(8): 891-905, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23652169

ABSTRACT

BACKGROUND: Many studies on colloids have recently been retracted, leaving us with uncertain evidence of their safety. We aimed to analyze whether intraoperative colloid administration is associated with postoperative complications. METHODS: The prospectively compiled database of the ARISCAT study of a large, representative cohort of general surgical patients was reanalyzed to compare outcomes according to whether intraoperative colloids were administered or not; a propensity score was used to adjust for potential confounders. The primary outcomes were major postoperative complications. Secondary outcomes were postoperative hospital-free days within 90 days and mortality at 30 and 90 days. In a retrospective survey we asked each center's data collectors to estimate the proportions of the different colloids administered during the study period. RESULTS: Of 2462 patients analyzed, 556 (22.6%) received some type of colloid intraoperatively. The median (25th-75th percentile) of total fluids administered was significantly higher in patients receiving colloids (10.0 [6.9-14.1] mL·kg-1·h-1 vs. 8.8 [6.0-12.8] mL·kg-1·h-1 for patients not receiving colloids; P<0.01). The median volume of colloids administered was 7.5 (6.3-10.4) mL·kg-1. An estimated 75.7% of the patients received third-generation hydroxyethyl starches (130/0.4). Significantly associated complications, after propensity score adjustment, were atelectasis, respiratory infection, bronchospasm, arrhythmia, sepsis, paralytic ileum, and hyperglycemia. Patients receiving colloids had 1.9 fewer postoperative hospital-free days (P<0.006). There were no significant differences in 30- and 90-day mortality. CONCLUSION: Our study suggests an association of intraoperative colloid administration, mainly of 130/0.4 hydroxyethyl starches, with diverse major postoperative complications and longer hospital stay. Controlled studies are urgently needed to assess the safety profile of colloid use in surgical patients.


Subject(s)
Colloids/adverse effects , Intraoperative Care/adverse effects , Medical Errors , Adult , Aged , Colloids/administration & dosage , Data Interpretation, Statistical , Female , Fluid Therapy/adverse effects , Humans , Infusions, Intravenous , Intraoperative Care/statistics & numerical data , Logistic Models , Male , Middle Aged , Propensity Score , Retrospective Studies , Treatment Outcome
16.
Rev Esp Anestesiol Reanim ; 59(5): 244-53, 2012 May.
Article in Spanish | MEDLINE | ID: mdl-22652333

ABSTRACT

OBJECTIVE: To assess the efficiency of pharmacological antiemetic prophylaxis in patients subjected to surgery under general anaesthetic in different postoperative nausea and vomiting (NVPO) risk groups. MATERIAL AND METHODS: A randomised, observational, prospective and multicentre cohort study was conducted. The study included 1239 patients from 26 hospitals who were subjected to elective surgery under general anaesthesia. The data collected included, demographic characteristics, the NVPO risk factors, anaesthetic technique, type of surgery, the duration, fluid therapy, antiemetic prophylaxis administered, and the incidence of NVPO in the first 24h after surgery. A stratified analysis (low, moderate and high risk) was performed with the intention of evaluating the relationship between prophylaxis and NVPO using a logistic regression model adjusted for propensity score. The number of patients needed to treat (NNT) to prevent an NVPO episode was then calculated for each of the strata. RESULTS: The incidence of NVPO in the low risk stratum was 21.6% without prophylaxis and 8.6% with prophylaxis, 31.3% compared to 17.7% in the moderate risk, and 46.5% compared to 32.7% in the high risk group. There was a significant protective effect in the three strata (odds ratio between treated and untreated patients) and in the NNT (95% CI) was 7 (5-11) in the low risk stratum, 7 (5-13) in that of the moderate risk, and 6 (4-16) in the high risk. CONCLUSIONS: The efficiency of pharmacological antiemetic prophylaxis in patients subjected to surgery under general anaesthesia was similar in all risk groups. Not providing antiemetic prophylaxis in low risk patients may not be justified due to the cost-effectiveness criteria. Future clinical guidelines to improve the quality of health care of patients operated on under general anaesthesia should consider the advantages of a universal NVPO prophylaxis.


Subject(s)
Anesthesia, General , Antiemetics/therapeutic use , Postoperative Nausea and Vomiting/prevention & control , Cohort Studies , Female , Humans , Incidence , Male , Middle Aged , Postoperative Nausea and Vomiting/epidemiology , Prospective Studies , Risk Factors
17.
Acta pediatr. esp ; 70(6): 262-263, jun. 2012. ilus
Article in Spanish | IBECS | ID: ibc-101539

ABSTRACT

Se presenta el caso de un recién nacido de 27 días de vida con una masa parotídea unilateral, sin otros hallazgos. Tras descartar causas infecciosas e inflamatorias, se realizaron estudios de imagen (ecografía y resonancia magnética) para establecer el diagnóstico definitivo de hemangioma parotídeo. El hemangioma representa el 50% de las raras masas parotídeas presentes en la infancia. La ausencia de lesiones premonitorias en la piel suprayacente en el periodo neonatal dificulta su diagnóstico. La resonancia magnética es la técnica exploratoria de elección, pues permite realizar un diagnóstico preciso evitando procedimientos invasivos, como la biopsia(AU)


A case report is presented of a 27 days old newborn with unilateral parotid mass with no other findings. After discarding infectious and inflammatory causes, image studies by ecography and magnetic resonance were carried out to establish a definitive diagnosis of parotid haemangioma. Haemangioma represents 50% of rare parotid masses in infancy. Absence of premonitory lesions in overlying skin, during the neonatal period, makes diagnosis difficult. Magnetic resonance is the exploration of choice as it allows a precise diagnosis there by avoiding invasive procedures such as biopsy(AU)


Subject(s)
Humans , Female , Infant, Newborn , Hemangioma/diagnosis , Parotid Gland/pathology , Parotid Gland , Magnetic Resonance Imaging/methods , Magnetic Resonance Imaging , Hemangioma , Parotid Neoplasms
18.
Rev. esp. anestesiol. reanim ; 59(5): 244-253, mayo 2012.
Article in Spanish | IBECS | ID: ibc-100719

ABSTRACT

Objetivo. Valorar la eficiencia de la profilaxis antiemética farmacológica en pacientes sometidos a una intervención quirúrgica, bajo anestesia general, en diferentes grupos de riesgo de náuseas y vomitos postoperatorios (NVPO). Material y métodos. Se diseñó un estudio multicéntrico aleatorio prospectivo observacional de cohortes. Se estudiaron 1.239 pacientes procedentes de 26 hospitales sometidos a cirugía programada con anestesia general. Fueron registradas las características poblacionales, los factores de riesgo de NVPO, la técnica anestésica, el tipo de cirugía, la duración, la fluidoterapia, la profilaxis antiemética administrada y la incidencia de NVPO en las primeras 24h. Se realizó un análisis estratificado (riesgo bajo, moderado y alto) encaminado a evaluar la asociación entre profilaxis y NVPO mediante un modelo de regresión logística ajustado por propensity score. Posteriormente, se calculó en cada uno de los estratos el número de pacientes que es necesario tratar (NNT), para evitar un episodio de NVPO. Resultados. La incidencia de NVPO en el estrato de bajo riesgo fue del 21,6% sin profilaxis y del 8,6% con profilaxis, en el de riesgo moderado fue del 31,3% frente al 17,7% y en el de alto riesgo del 46,5% frente al 32,7%. Hubo un efecto protector de la profilaxis de forma significativa en los 3 estratos (odds ratio entre pacientes tratados y no tratados) y el NNT (IC del 95%) fue de 7 (5-11) en el estrato de bajo riesgo, 7 (5-13) en el de riesgo moderado y 6 (4-16) en el de riesgo elevado. Conclusiones. La eficiencia de la profilaxis antiemética farmacológica en pacientes sometidos a cirugía con anestesia general fue similar en todos los grupos de riesgo. La privación de profilaxis antiemética en los pacientes de bajo riesgo puede no estar justificada por criterios de coste-efectividad. Las futuras guías clínicas para la mejora de la calidad asistencial, de los pacientes intervenidos con anestesia general deberán considerar la conveniencia de una profilaxis universal de las NVPO(AU)


Objective. To assess the efficiency of pharmacological antiemetic prophylaxis in patients subjected to surgery under general anaesthetic in different postoperative nausea and vomiting (NVPO) risk groups. Material and methods. A randomised, observational, prospective and multicentre cohort study was conducted. The study included 1239 patients from 26 hospitals who were subjected to elective surgery under general anaesthesia. The data collected included, demographic characteristics, the NVPO risk factors, anaesthetic technique, type of surgery, the duration, fluid therapy, antiemetic prophylaxis administered, and the incidence of NVPO in the first 24h after surgery. A stratified analysis (low, moderate and high risk) was performed with the intention of evaluating the relationship between prophylaxis and NVPO using a logistic regression model adjusted for propensity score. The number of patients needed to treat (NNT) to prevent an NVPO episode was then calculated for each of the strata. Results. The incidence of NVPO in the low risk stratum was 21.6% without prophylaxis and 8.6% with prophylaxis, 31.3% compared to 17.7% in the moderate risk, and 46.5% compared to 32.7% in the high risk group. There was a significant protective effect in the three strata (odds ratio between treated and untreated patients) and in the NNT (95% CI) was 7 (5-11) in the low risk stratum, 7 (5-13) in that of the moderate risk, and 6 (4-16) in the high risk. Conclusions. The efficiency of pharmacological antiemetic prophylaxis in patients subjected to surgery under general anaesthesia was similar in all risk groups. Not providing antiemetic prophylaxis in low risk patients may not be justified due to the cost-effectiveness criteria. Future clinical guidelines to improve the quality of health care of patients operated on under general anaesthesia should consider the advantages of a universal NVPO prophylaxis(AU)


Subject(s)
Humans , Male , Female , Risk Groups , Antiemetics/therapeutic use , Anesthesia, General/methods , Anesthesia, General , Postoperative Nausea and Vomiting/complications , Postoperative Nausea and Vomiting/therapy , Risk Factors , Antibiotic Prophylaxis/methods , Treatment Outcome , Evaluation of the Efficacy-Effectiveness of Interventions , Antiemetics/metabolism , Antiemetics/pharmacology , Prospective Studies , Fluid Therapy/methods , Fluid Therapy , Odds Ratio
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