Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants
DEGA
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFebruary 21, 2021
March 1, 2017
5.1 years
August 4, 2015
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Bayley scores at 2 years
2 years
Other Outcomes (3)
Surgical success rate
4 hours
Peri-operative apnea episodes
24 hours
Peri-operative bradycardic episodes
24 hours
Study Arms (2)
Dex Group
EXPERIMENTALIntravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery.
GA Group
ACTIVE COMPARATORGeneral 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.
Interventions
Patients receive general sevoflurane anaesthesia with endotracheal intubation
Infant inguinal hernia repair.
Eligibility Criteria
You may qualify if:
- Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KK Women's and Children's Hospitallead
- Singhealth Foundationcollaborator
- Institute for Human Development and Potential (IHDP), Singaporecollaborator
- Duke-NUS Graduate Medical Schoolcollaborator
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Related Publications (4)
Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
PMID: 12574416BACKGROUNDSanders RD, Sun P, Patel S, Li M, Maze M, Ma D. Dexmedetomidine provides cortical neuroprotection: impact on anaesthetic-induced neuroapoptosis in the rat developing brain. Acta Anaesthesiol Scand. 2010 Jul;54(6):710-6. doi: 10.1111/j.1399-6576.2009.02177.x. Epub 2009 Dec 9.
PMID: 20003127BACKGROUNDMahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226.
PMID: 26170346BACKGROUNDBong CL, Tan J, Lim S, Low Y, Sim SW, Rajadurai VS, Khoo PC, Allen J, Meaney M, Koh WP. Randomised controlled trial of dexmedetomidine sedation vs general anaesthesia for inguinal hernia surgery on perioperative outcomes in infants. Br J Anaesth. 2019 May;122(5):662-670. doi: 10.1016/j.bja.2018.12.027. Epub 2019 Mar 7.
PMID: 30916007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choon L Bong, MBChB FRCA
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
September 24, 2015
Study Start
July 1, 2015
Primary Completion
July 20, 2020
Study Completion
January 31, 2021
Last Updated
February 21, 2021
Record last verified: 2017-03