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Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.

ABSTRACT: BACKGROUND:Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants. The aim of the study is to describe success and failure rates of RA and report factors associated with failure. METHODS:This was a nested cohort study within a prospective, randomized, controlled, observer-blind, equivalence trial. Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA (spinal, caudal epidural, or combined spinal caudal anesthetic) or GA with sevoflurane. The data of 339 infants, where spinal or combined spinal caudal anesthetic was attempted, were analyzed. Possible predictors of failure were assessed including patient factors, technique, experience of site and anesthetist, and type of local anesthetic. RESULTS:RA was sufficient for the completion of surgery in 83.2% of patients. Spinal anesthesia was successful in 86.9% of cases and combined spinal caudal anesthetic in 76.1%. Thirty-four patients required conversion to GA, and an additional 23 patients (6.8%) required brief sedation. Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure (odds ratio = 2.46). CONCLUSIONS:The failure rate of spinal anesthesia was low. Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone.

SUBMITTER: Frawley G

PROVIDER: S-EPMC4626278 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.

Frawley Geoff G Bell Graham G Disma Nicola N Withington Davinia E DE de Graaff Jurgen C JC Morton Neil S NS McCann Mary Ellen ME Arnup Sarah J SJ Bagshaw Oliver O Wolfler Andrea A Bellinger David D Davidson Andrew J AJ

Anesthesiology 20150701 1

<h4>Background</h4>Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants. The aim of the study is to describe success ...[more]

PMID: 26001028

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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: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).

Project description:IntroductionInguinal hernia repair is a common procedure and a priority for public health efforts in Ghana. It is essential that inguinal hernia repair be performed in a safe, efficient manner to justify its widespread use. Local anesthesia has many favorable properties and has been shown to be superior, compared to regional or general anesthesia, in terms of pain control, safety profile, cost-effectiveness, resources required, and time to discharge. Local anesthesia is recommended for open repair of reducible hernias, provided clinician experience, by multiple international guidelines. Regional anesthesia is associated with myocardial infarction and other complications, and its use is discouraged by multiple guidelines, especially in older patients. This study aims to assess the current state of anesthesia for inguinal hernia repair in the northern and transitional zone of Ghana. In addition we will assess the perceptions of different types of anesthesia along with understanding of evidence-based guidelines among clinicians participating in inguinal hernia repair.MethodsWe performed a retrospective review of all inguinal hernia repairs for male patients, 18 and older, in over 90% of hospitals in northern Ghana. All 41 hospitals were visited and caselogs and patient charts were manually reviewed to extract data. Multivariate logistic regression was used to determine predictors of local anesthesia use. We designed a survey instrument to assess the perceptions of physicians and anesthetists regarding different types of anesthesia for inguinal hernia repair. The survey was designed by a Ghanaian surgeon, reviewed by all co-authors, and tested prior to implementation using a sample (n = 8) of clinicians having similar practices to those of the survey population. Of 70 clinicians, 66 responded, yielding a response rate of 94%.Results8080 patients underwent hernia repair of which 37% were performed under local anesthesia, while the majority, 60%, were performed under regional anesthesia. Negative predictors of local anesthesia were emergent repair (OR = 0.258, p < 0.001), surgery performed at a teaching hospital (OR = 0.105, p < 0.001), and bilateral hernia repair (OR = 0.374, p < 0.001). 1,839 (22.8%) of IH repairs were done on patients age 65 or older and RA was most frequently used among the elderly population (57.8%), while local anesthesia was used 39.5% of the time. Sixty-six clinicians participated in the survey with the majority reporting that local anesthesia requires fewer staff, less equipment, has a shorter recovery, is more cost-effective, and might be safer for patients. However 66% were unfamiliar with or incorrectly perceived international guidelines.ConclusionTo our knowledge, this study is the largest assessment of anesthesia use for inguinal hernia repair in an LMIC. Although the selection of anesthetic technique should be guided by a patient's general health, the anatomy of the hernia, and clinician judgment, local anesthesia appears to be underutilized in northern Ghana. Survey responses demonstrate high rates of unfamiliarity or incorrectly perceived evidence-based guidelines. Future research should assess how education on the benefits and technique of local anesthesia administration may further increase rates for inguinal hernia repair, especially for older patients.

Project description:BackgroundIn laboratory animals, exposure to most general anaesthetics leads to neurotoxicity manifested by neuronal cell death and abnormal behaviour and cognition. Some large human cohort studies have shown an association between general anaesthesia at a young age and subsequent neurodevelopmental deficits, but these studies are prone to bias. Others have found no evidence for an association. We aimed to establish whether general anaesthesia in early infancy affects neurodevelopmental outcomes.MethodsIn this international, assessor-masked, equivalence, randomised, controlled trial conducted at 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand, we recruited infants of less than 60 weeks' postmenstrual age who were born at more than 26 weeks' gestation and were undergoing inguinal herniorrhaphy, without previous exposure to general anaesthesia or risk factors for neurological injury. Patients were randomly assigned (1:1) by use of a web-based randomisation service to receive either awake-regional anaesthetic or sevoflurane-based general anaesthetic. Anaesthetists were aware of group allocation, but individuals administering the neurodevelopmental assessments were not. Parents were informed of their infants group allocation upon request, but were told to mask this information from assessors. The primary outcome measure was full-scale intelligence quotient (FSIQ) on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III), at 5 years of age. The primary analysis was done on a per-protocol basis, adjusted for gestational age at birth and country, with multiple imputation used to account for missing data. An intention-to-treat analysis was also done. A difference in means of 5 points was predefined as the clinical equivalence margin. This completed trial is registered with ANZCTR, number ACTRN12606000441516, and ClinicalTrials.gov, number NCT00756600.FindingsBetween Feb 9, 2007, and Jan 31, 2013, 4023 infants were screened and 722 were randomly allocated: 363 (50%) to the awake-regional anaesthesia group and 359 (50%) to the general anaesthesia group. There were 74 protocol violations in the awake-regional anaesthesia group and two in the general anaesthesia group. Primary outcome data for the per-protocol analysis were obtained from 205 children in the awake-regional anaesthesia group and 242 in the general anaesthesia group. The median duration of general anaesthesia was 54 min (IQR 41-70). The mean FSIQ score was 99·08 (SD 18·35) in the awake-regional anaesthesia group and 98·97 (19·66) in the general anaesthesia group, with a difference in means (awake-regional anaesthesia minus general anaesthesia) of 0·23 (95% CI -2·59 to 3·06), providing strong evidence of equivalence. The results of the intention-to-treat analysis were similar to those of the per-protocol analysis.InterpretationSlightly less than 1 h of general anaesthesia in early infancy does not alter neurodevelopmental outcome at age 5 years compared with awake-regional anaesthesia in a predominantly male study population.FundingUS National Institutes of Health, US Food and Drug Administration, Thrasher Research Fund, Australian National Health and Medical Research Council, Health Technologies Assessment-National Institute for Health Research (UK), Australian and New Zealand College of Anaesthetists, Murdoch Children's Research Institute, Canadian Institutes of Health Research, Canadian Anesthesiologists Society, Pfizer Canada, Italian Ministry of Health, Fonds NutsOhra, UK Clinical Research Network, Perth Children's Hospital Foundation, the Stan Perron Charitable Trust, and the Callahan Estate.

Project description:IntroductionPreterm neonatal mortality contributes substantially to the high neonatal mortality globally. In Uganda, preterm neonatal mortality accounts for 31% of all neonatal deaths. Previous studies have shown variability in mortality rates by healthcare setting. Also, different predictors influence the risk of neonatal mortality in different populations. Understanding the predictors of preterm neonatal mortality in the low-resource setting where we conducted our study could guide the development of interventions to improve outcomes for preterm neonates. We thus aimed to determine the incidence and predictors of mortality among preterm neonates born at Mbarara Regional Referral Hospital (MRRH) in South Western Uganda.MethodsWe prospectively enrolled 538 live preterm neonates born at MRRH from October 2019 to September 2020. The neonates were followed up until death or 28 days, whichever occurred first. We used Kaplan Meier survival analysis to describe preterm neonatal mortality and Cox proportional hazards regression to assess predictors of preterm neonatal mortality over a maximum of 28 days of follow up.ResultsThe cumulative incidence of preterm neonatal mortality was 19.8% (95% C.I: 16.7-23.5) at 28 days from birth. Birth asphyxia (adjusted hazard ratio [aHR], 14.80; 95% CI: 5.21 to 42.02), not receiving kangaroo mother care (aHR, 9.50; 95% CI: 5.37 to 16.78), delayed initiation of breastfeeding (aHR, 9.49; 95% CI: 2.84 to 31.68), late antenatal care (ANC) booking (aHR, 1.81 to 2.52; 95% CI: 1.11 to 7.11) and no ANC attendance (aHR, 3.56; 95% CI: 1.51 to 8.43), vaginal breech delivery (aHR, 3.04; 95% CI: 1.37 to 5.18), very preterm births (aHR, 3.17; 95% CI: 1.24 to 8.13), respiratory distress syndrome (RDS) (aHR, 2.50; 95% CI: 1.11 to 5.64) and hypothermia at the time of admission to the neonatal unit (aHR, 1.98; 95% CI: 1.18 to 3.33) increased the risk of preterm neonatal mortality. Attending more than 4 ANC visits (aHR, 0.35; 95% CI: 0.12 to 0.96) reduced the risk of preterm neonatal mortality.ConclusionsWe observed a high cumulative incidence of mortality among preterm neonates born at a low-resource regional referral hospital in Uganda. The predictors of mortality among preterm neonates were largely modifiable factors occurring in the prenatal, natal and postnatal period (lack of ANC attendance, late ANC booking, vaginal breech delivery, birth asphyxia, respiratory distress syndrome, and hypothermia at the time of admission to the neonatal unit, not receiving kangaroo mother care and delayed initiation of breastfeeding). These findings suggest that investment in and enhancement of ANC attendance, intrapartum care, and the feasible essential newborn care interventions by providing the warm chain through kangaroo mother care, encouraging early initiation of breastfeeding, timely resuscitation for neonates when indicated and therapies reducing the incidence and severity of RDS could improve outcomes among preterm neonates in this setting.

Dataset Information

Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.

Publications

Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.

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