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

February 18, 2021 updated by: KK Women's and Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

Singapore Institute for Clinical Sciences
Duke-NUS Graduate Medical School
Singhealth Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 20, 2020

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHF/CTG055/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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