Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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

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Neurodevelopmental Disorder Bilateral Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dex Group

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

Group Type EXPERIMENTAL

Dexmedetomidine sedation

Intervention Type DRUG

Patients receive dexmedetomidine sedation

Caudal anaesthesia

Intervention Type PROCEDURE

single shot caudal anaesthesia

Inguinal hernia surgery

Intervention Type PROCEDURE

Infant inguinal hernia repair.

GA Group

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.

Group Type ACTIVE_COMPARATOR

General sevoflurane anaesthesia

Intervention Type DRUG

Patients receive general sevoflurane anaesthesia with endotracheal intubation

Caudal anaesthesia

Intervention Type PROCEDURE

single shot caudal anaesthesia

Inguinal hernia surgery

Intervention Type PROCEDURE

Infant inguinal hernia repair.

Interventions

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Dexmedetomidine sedation

Patients receive dexmedetomidine sedation

Intervention Type DRUG

General sevoflurane anaesthesia

Patients receive general sevoflurane anaesthesia with endotracheal intubation

Intervention Type DRUG

Caudal anaesthesia

single shot caudal anaesthesia

Intervention Type PROCEDURE

Inguinal hernia surgery

Infant inguinal hernia repair.

Intervention Type PROCEDURE

Other Intervention Names

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Dex Gas Caudal Inguinal herniotomy

Eligibility Criteria

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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.

Minimum Eligible Age

34 Weeks

Maximum Eligible Age

54 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes