NCT02559102

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery on Peri-operative Outcomes and Neurocognitive Development in Infants: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 34 Weeks – 54 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

Several epidemiologic studies have suggested that children exposed to general anaesthesia (GA) in early childhood may be at increased risk of subsequent learning disabilities and behavioural problems. Animal studies have shown that exposure to GA agents during critical neuro-developmental windows induces neuronal apoptosis. All commonly used anaesthetic agents induce neurotoxicity with the exception of dexmedetomidine, a highly specific alpha-2 agonist which has been shown to be neuroprotective. GA is the current standard of care for inguinal hernia repair in infants at KKH. The investigators recently demonstrated that dexmedetomidine sedation with caudal block is a feasible alternative for inguinal hernia repair in infants below 3 months of age. This prospective randomized controlled trial will compare the early and long-term outcomes of infants following inguinal hernia surgery using dexmedetomidine sedation with caudal block versus GA with caudal block. This study aims: 1. To compare the neurodevelopment at 6 months and 2years, of infants randomized to dexmedetomidine sedation with caudal block with those randomized to GA with caudal block for inguinal hernia surgery before 3 months of age. 2. To compare the efficacy of dexmedetomidine sedation with caudal block versus GA with caudal block for inguinal hernia surgery, in terms of duration of anaesthesia, duration of surgery and surgeon's satisfaction with intraoperative conditions.

Conditions

• Neurodevelopmental Disorder
• Bilateral Inguinal Hernia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine sedation	Patients receive dexmedetomidine sedation
DRUG	General sevoflurane anaesthesia	Patients receive general sevoflurane anaesthesia with endotracheal intubation
PROCEDURE	Caudal anaesthesia	single shot caudal anaesthesia
PROCEDURE	Inguinal hernia surgery	Infant inguinal hernia repair.

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-07-20
• Completion: 2021-01-31
• First posted: 2015-09-24
• Last updated: 2021-02-21

Locations

1 site across 1 country: Singapore