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Completed

NCT Number: NCT02559102

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

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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Key information

Age range

34 week–54 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine sedation

Drug

Patients receive dexmedetomidine sedation

Other names: Dex

General sevoflurane anaesthesia

Drug

Patients receive general sevoflurane anaesthesia with endotracheal intubation

Other names: Gas

Caudal anaesthesia

Procedure

single shot caudal anaesthesia

Other names: Caudal

Inguinal hernia surgery

Procedure

Infant inguinal hernia repair.

Other names: Inguinal herniotomy

Primary outcomes

  1. Deferred Imitation scores at 6 months

    Time frame: 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 outcomes

  1. Bayley scores at 2 years

    Time frame: 2 years

    Bayleys scales of Infant Development version III

Other outcomes

  1. Surgical success rate

    Time frame: 4 hours

    Success rate of surgery with assigned technique, without requiring further adjuvants.

  2. Peri-operative apnea episodes

    Time frame: 24 hours

    Number of episodes of apnea intra-operatively, in PACU, and in ward.

  3. Peri-operative bradycardic episodes

    Time frame: 24 hours

    Number of episodes of bradycardia intra-operatively, in PACU, and in ward.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Duke-NUS Graduate Medical School
  • Institute for Human Development and Potential (IHDP), Singapore
  • Singhealth Foundation

Registry information

Official study title

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

Acronym: DEGA

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 24, 2015
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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