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Clinical Trials/ISRCTN12437565
ISRCTN12437565
Completed
未知

A multicentre randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants

HS Greater Glasgow and Clyde and University of Glasgow (UK)0 sites660 target enrollmentJune 3, 2009

Overview

Phase
未知
Intervention
Not specified
Conditions
Anaesthesia for unilateral or bilateral inguinal hernia repair
Sponsor
HS Greater Glasgow and Clyde and University of Glasgow (UK)
Enrollment
660
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 3, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
HS Greater Glasgow and Clyde and University of Glasgow (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
  • 2\. Any infant whose gestational age (GA) is 26 weeks or more (GA \= 182 days)
  • 3\. Any infant whose post\-menstrual age (PMA) is up to 60 weeks (PMA \= 426 days)
  • Minimum age: 26 weeks
  • Maximum age: 60 weeks
  • Gender: both males and females

Exclusion Criteria

  • 1\. Any child older than 60 weeks post\-menstrual age
  • 2\. Any child born at less than 26 weeks gestation
  • 3\. Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)
  • 4\. Pre\-operative ventilation immediately prior to surgery
  • 5\. Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy
  • 6\. Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
  • 7\. Children where follow\-up would be difficult for geographic or social reasons
  • 8\. Families where English (or French for Paris and Montreal sites) is not the language spoken at home
  • 9\. Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra\-ventricular haemorrhage (IVH) (\+/\- post\-haemorrhage ventricular dilatation)
  • 10\. Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero

Outcomes

Primary Outcomes

Not specified

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