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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02559102

Acronym

DEGA

Enrollment

104

Registered

2015-09-24

Start date

2015-07-31

Completion date

2021-01-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Inguinal Hernia, Neurodevelopmental Disorder

Keywords

Dexmedetomidine sedation, General anaesthesia, Neurodevelopment, Infants, Neonates

Brief 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.

Interventions

DRUGDexmedetomidine sedation

Patients receive dexmedetomidine sedation

DRUGGeneral sevoflurane anaesthesia

Patients receive general sevoflurane anaesthesia with endotracheal intubation

PROCEDURECaudal anaesthesia

single shot caudal anaesthesia

PROCEDUREInguinal hernia surgery

Infant inguinal hernia repair.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

34 Weeks to 54 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Deferred Imitation scores at 6 months	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).

Secondary

Measure	Time frame	Description
Bayley scores at 2 years	2 years	Bayleys scales of Infant Development version III

Other

Measure	Time frame	Description
Surgical success rate	4 hours	Success rate of surgery with assigned technique, without requiring further adjuvants.
Peri-operative apnea episodes	24 hours	Number of episodes of apnea intra-operatively, in PACU, and in ward.
Peri-operative bradycardic episodes	24 hours	Number of episodes of bradycardia intra-operatively, in PACU, and in ward.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026