CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 643 enrolled
Drug / intervention
Regional Anesthesia +1 moredrug
Likely dose
Regional Anesthesia 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00756600
NCT00756600Phase 4Completed
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A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants

Boston Children's Hospital·interventional·Posted Sep 22, 2008·Updated Apr 29, 2020

In Brief

A Phase 4 clinical trial evaluating Regional Anesthesia and General Anesthesia for Inguinal Hernia. Completed, enrolled 643 participants across 30 sites in 7 countries.

Detailed Summary

The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInguinal Hernia
CountriesAustralia, Canada, Italy, Netherlands, New Zealand, United Kingdom, United States
CollaboratorsRoyal Children's Hospital, Royal Hospital for Sick Children, Murdoch Childrens Research Institute, Food and Drug Administration (FDA)

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2008
Enrollment StartOct 23, 2006
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 17.8 years ago

Interventions

Regional Anesthesiadrug

Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.

General Anesthesiadrug

Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.