Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

Study Overview
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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.

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: 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. 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.

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

Conditions
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Neurodevelopmental Disorder, Bilateral Inguinal Hernia

Intervention / Treatment
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* Drug: Dexmedetomidine sedation
* Drug: General sevoflurane anaesthesia
* Procedure: Caudal anaesthesia
* Procedure: Inguinal hernia surgery


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 54 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dex Group<br>Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery. | Drug: Dexmedetomidine sedation<br>* Patients receive dexmedetomidine sedation<br>* Other names: Dex;Procedure: Caudal anaesthesia<br>* single shot caudal anaesthesia<br>* Other names: Caudal;Procedure: Inguinal hernia surgery<br>* Infant inguinal hernia repair.<br>* Other names: Inguinal herniotomy;|
| Active Comparator: GA Group<br>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. | Drug: General sevoflurane anaesthesia<br>* Patients receive general sevoflurane anaesthesia with endotracheal intubation<br>* Other names: Gas;Procedure: Caudal anaesthesia<br>* single shot caudal anaesthesia<br>* Other names: Caudal;Procedure: Inguinal hernia surgery<br>* Infant inguinal hernia repair.<br>* Other names: Inguinal herniotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deferred Imitation scores at 6 months | Deferred imitation, test of declarative memory. Infants are assessed when first shown the target actions (DF1) and again on how well they reproduce the actions (DF2). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley scores at 2 years | Bayleys scales of Infant Development version III | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine sedation, General anaesthesia, Neurodevelopment, Infants, Neonates