Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

Neurodevelopmental Disorder Clinical Trial

— DEGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559102
• Other study ID #: SHF/CTG055/2014
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2017
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 31, 2021
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 54 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral Inguinal Hernia
• Hernia
• Hernia, Inguinal
• Neurodevelopmental Disorder
• Neurodevelopmental Disorders

Intervention

Drug:
• Dexmedetomidine sedation
Patients receive dexmedetomidine sedation
• General sevoflurane anaesthesia
Patients receive general sevoflurane anaesthesia with endotracheal intubation

Procedure:
• Caudal anaesthesia
single shot caudal anaesthesia
• Inguinal hernia surgery
Infant inguinal hernia repair.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Duke-NUS Graduate Medical School, Singapore Institute for Clinical Sciences, Singhealth Foundation

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View Citation

Mahmoud 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. Review. — View Citation

Sanders 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical success rate	Success rate of surgery with assigned technique, without requiring further adjuvants.	4 hours
Other	Peri-operative apnea episodes	Number of episodes of apnea intra-operatively, in PACU, and in ward.	24 hours
Other	Peri-operative bradycardic episodes	Number of episodes of bradycardia intra-operatively, in PACU, and in ward.	24 hours
Primary	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	Bayley scores at 2 years	Bayleys scales of Infant Development version III	2 years