CompletedPhase 3

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

Singapore104 participantsStarted 2015-07

Plain-language summary

This is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age. The investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.

Who can participate

Age range34 Weeks – 54 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH. Exclusion Criteria: * History of prematurity younger than 28 weeks gestation, * Requirement for CPAP greater than 6 cmH20 at time of surgery * Significant cardiac pathology or cardiac conduction defects * Unusually large hernia sacs * Any contraindication for caudal anesthesia * Surgeon refusal on account of anticipated prolonged or difficult surgery.

What they're measuring

Deferred Imitation scores at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT02559102

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-07-20

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