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Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

NCT02559102 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-02-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexmedetomidine sedation

Patients receive dexmedetomidine sedation

DRUG

General sevoflurane anaesthesia

Patients receive general sevoflurane anaesthesia with endotracheal intubation

PROCEDURE

Caudal anaesthesia

single shot caudal anaesthesia

PROCEDURE

Inguinal hernia surgery

Infant inguinal hernia repair.

Sponsors & Collaborators

  • Singhealth Foundation

    collaborator OTHER_GOV

  • Institute for Human Development and Potential (IHDP), Singapore

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Choon L Bong, MBChB FRCA · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
54 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-07-20
Completion
2021-01-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559102 on ClinicalTrials.gov