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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002878-35-IT

Enrollment

660

Registered

2009-03-20

Start date

2008-07-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia MedDRA version: 9.1 Level: LLT Classification code 10022016 Term: Inguinal hernia

Interventions

Trade Name: SEVORANE*INAL 250ML SECUR LOCK Pharmaceutical Form: Inhalation gas INN or Proposed INN: Sevoflurane Concentration unit: % percent Concentration type: equal Concentration number: 2-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026