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| Name | Class |
|---|---|
| Singhealth Foundation | OTHER_GOV |
| Institute for Human Development and Potential (IHDP), Singapore | OTHER |
| Duke-NUS Graduate Medical School | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex Group | Experimental | Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery. |
|
| GA Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine sedation | Drug | Patients receive dexmedetomidine sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley scores at 2 years | Bayleys scales of Infant Development version III | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical success rate | Success rate of surgery with assigned technique, without requiring further adjuvants. | 4 hours |
| Peri-operative apnea episodes | Number of episodes of apnea intra-operatively, in PACU, and in ward. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choon L Bong, MBChB FRCA | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12574416 | Background | 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. | |
| 20003127 |
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| General sevoflurane anaesthesia | Drug | Patients receive general sevoflurane anaesthesia with endotracheal intubation |
|
|
| Caudal anaesthesia | Procedure | single shot caudal anaesthesia |
|
|
| Inguinal hernia surgery | Procedure | Infant inguinal hernia repair. |
|
|
| 24 hours |
| Peri-operative bradycardic episodes | Number of episodes of bradycardia intra-operatively, in PACU, and in ward. | 24 hours |
| 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. |
| 26170346 | Background | 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. |
| 30916007 | Derived | Bong 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. |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005740 | Gases |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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