Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants (DEGA)

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Bilateral Inguinal Hernia; Neurodevelopmental Disorder

Treatments: Drug: Dexmedetomidine sedation; Drug: General sevoflurane anaesthesia; Procedure: Caudal anaesthesia; Procedure: Inguinal hernia surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02559102

SHF/CTG055/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 34 to 54 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

Dex Group

Experimental group

Description:

Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery.

Treatment:

Procedure: Inguinal hernia surgery

Procedure: Caudal anaesthesia

Drug: Dexmedetomidine sedation

GA Group

Active Comparator group

Description:

General sevoflurane anaesthesia with endotracheal intubation and single shot caudal anaesthesia for inguinal hernia surgery. This is currently the standard anaesthetic technique for bilateral inguinal hernia surgery in neonates and infants in KKH.

Treatment:

Procedure: Inguinal hernia surgery

Procedure: Caudal anaesthesia

Drug: General sevoflurane anaesthesia