The GAS study. A multi-site RCT comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants - GAS study

Conditions: Inguinal Hernia
MedDRA version: 9.1Level: LLTClassification code 10022016Term: Inguinal hernia

Registration Number: EUCTR2008-002878-35-IT

Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 660

Inclusion Criteria

Any child scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Any child older than 60 weeks postmenstrual age · Any child born at less than 26 weeks gestation · Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy) · Pre-operative ventilation immediately prior to surgery · Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy (PDA alone is not an exclusion criterion)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes.;Secondary Objective: Secondary objectives are to describe the frequency and characteristics of apnoea in the post-operative period after both regional and general anaesthesia for inguinal hernia repair in infants, and determine the factors associated with apnoea.;Primary end point(s): The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes.

Secondary Outcome Measures