Dataset Information

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. METHODS:Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded. RESULTS:Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio [OR], 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature. CONCLUSIONS:RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.

SUBMITTER: Davidson AJ

PROVIDER: S-EPMC4626294 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

Davidson Andrew J AJ Morton Neil S NS Arnup Sarah J SJ de Graaff Jurgen C JC Disma Nicola N Withington Davinia E DE Frawley Geoff G Hunt Rodney W RW Hardy Pollyanna P Khotcholava Magda M von Ungern Sternberg Britta S BS Wilton Niall N Tuo Pietro P Salvo Ida I Ormond Gillian G Stargatt Robyn R Locatelli Bruno Guido BG McCann Mary Ellen ME

Anesthesiology 20150701 1

<h4>Background</h4>Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia.<h4>Methods</h4>Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, ...[more]

PMID: 26001033

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Project description:BACKGROUND:The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS trial is to compare rates of intraoperative hypotension after anesthesia and to identify risk factors for intraoperative hypotension. METHODS:A total of 722 infants ?60 weeks postmenstrual age undergoing inguinal herniorrhaphy were randomized to either bupivacaine regional anesthesia (RA) or sevoflurane GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born at <26 weeks of gestation. Moderate hypotension was defined as mean arterial pressure measurement of <35 mm Hg. Any hypotension was defined as mean arterial pressure of <45 mm Hg. Epochs were defined as 5-minute measurement periods. The primary outcome was any measured hypotension <35 mm Hg from start of anesthesia to leaving the operating room. This analysis is reported primarily as intention to treat (ITT) and secondarily as per protocol. RESULTS:The relative risk of GA compared with RA predicting any measured hypotension of <35 mm Hg from the start of anesthesia to leaving the operating room was 2.8 (confidence interval [CI], 2.0-4.1; P < .001) by ITT analysis and 4.5 (CI, 2.7-7.4, P < .001) as per protocol analysis. In the GA group, 87% and 49%, and in the RA group, 41% and 16%, exhibited any or moderate hypotension by ITT, respectively. In multivariable modeling, group assignment (GA versus RA), weight at the time of surgery, and minimal intraoperative temperature were risk factors for hypotension. Interventions for hypotension occurred more commonly in the GA group compared with the RA group (relative risk, 2.8, 95% CI, 1.7-4.4 by ITT). CONCLUSIONS:RA reduces the incidence of hypotension and the chance of intervention to treat it compared with sevoflurane anesthesia in young infants undergoing inguinal hernia repair.

Project description:BackgroundTotal hip arthroplasty may be performed under general or spinal anesthesia. The purpose of the current study was to compare perioperative outcomes between anesthetic types for patients undergoing primary elective total hip arthroplasty.MethodsPatients who had undergone primary elective total hip arthroplasty from 2010 to 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Operating room times, length of stay, thirty-day adverse events, and readmission were compared between patients who had received general anesthesia and those who had received spinal anesthesia. Propensity-adjusted multivariate analysis was used to control for selection bias and baseline patient characteristics.ResultsA total of 20,936 patients who had undergone total hip arthroplasty met inclusion criteria for this study. Of these, 12,752 patients (60.9%) had received general anesthesia and 8184 patients (39.1%) had received spinal anesthesia. On propensity-adjusted multivariate analyses, general anesthesia for total hip arthroplasty was associated with increased operative time (+12 minutes [95% confidence interval, +11 to +13 minutes]; p < 0.001) and postoperative room time (+5 minutes [95% confidence interval, +4 to +6 minutes]; p < 0.001). General anesthesia was also associated with the occurrence of any adverse event (odds ratio, 1.31 [95% confidence interval, 1.23 to 1.41]; p < 0.001), prolonged postoperative ventilator use (odds ratio, 5.81 [95% confidence interval, 1.35 to 25.06]; p = 0.018), unplanned intubation (odds ratio, 2.17 [95% confidence interval, 1.11 to 4.29]; p = 0.024), stroke (odds ratio, 2.51 [95% confidence interval, 1.02 to 6.20]; p = 0.046), cardiac arrest (odds ratio, 5.04 [95% confidence interval, 1.15 to 22.07]; p = 0.032), any minor adverse event (odds ratio, 1.35 [95% confidence interval, 1.25 to 1.45]; p = 0.001), and blood transfusion (odds ratio, 1.34 [95% confidence interval, 1.25 to 1.45]; p < 0.001). General anesthesia was not associated with any difference in preoperative room time, postoperative length of stay, or readmission.ConclusionsGeneral anesthesia was associated with an increased rate of adverse events and mildly increased operating room times.

Project description:BackgroundPreclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial.MethodsIn this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600.FindingsBetween Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as-per-protocol analysis, the cognitive composite score (mean [SD]) was 98.6 (14.2) in the awake-regional group and 98.2 (14.7) in the general anaesthesia group. There was equivalence in mean between groups (awake-regional minus general anaesthesia 0.169, 95% CI -2.30 to 2.64). The median duration of anaesthesia in the general anaesthesia group was 54 min.InterpretationFor this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia.FundingAustralia National Health and Medical Research Council (NHMRC), Health Technologies Assessment-National Institute for Health Research UK, National Institutes of Health, Food and Drug Administration, Australian and New Zealand College of Anaesthetists, Murdoch Childrens Research Institute, Canadian Institute of Health Research, Canadian Anesthesiologists' Society, Pfizer Canada, Italian Ministry of Heath, Fonds NutsOhra, and UK Clinical Research Network (UKCRN).

Dataset Information

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

Publications

Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

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