KK Women's and Children's Hospital
Singapore, 229899
NCT Number: NCT02559102
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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Notify Me34 week–54 week
All sexes
Interventional
Phase 3
Singapore, 229899
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive dexmedetomidine sedation
Other names: Dex
Patients receive general sevoflurane anaesthesia with endotracheal intubation
Other names: Gas
single shot caudal anaesthesia
Other names: Caudal
Infant inguinal hernia repair.
Other names: Inguinal herniotomy
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).
Time frame: 2 years
Bayleys scales of Infant Development version III
Time frame: 4 hours
Success rate of surgery with assigned technique, without requiring further adjuvants.
Time frame: 24 hours
Number of episodes of apnea intra-operatively, in PACU, and in ward.
Time frame: 24 hours
Number of episodes of bradycardia intra-operatively, in PACU, and in ward.
KK Women's and Children's Hospital
Other Gov
Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery on Peri-operative Outcomes and Neurocognitive Development in Infants: A Randomized Controlled Trial
Acronym: DEGA
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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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