Neurodevelopmental DisorderPhase 3DEGANCT02559102
Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants
A Phase 3 study testing Dexmedetomidine sedation, General sevoflurane anaesthesia and Caudal anaesthesia in people with Neurodevelopmental Disorder and Bilateral Inguinal Hernia, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 34 to 54 weeksHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorder, Bilateral Inguinal Hernia
- What is being tested?
- Dexmedetomidine sedation, General sevoflurane anaesthesia and Caudal anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2015to 31 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 54 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery on Peri-operative Outcomes and Neurocognitive Development in Infants: A Randomized Controlled Trial
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.
Read the detailed 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:
- 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.
- 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.
- Being tested
- Dexmedetomidine sedation, General sevoflurane anaesthesia, Caudal anaesthesia, Inguinal hernia surgery
- Keywords
- Dexmedetomidine sedation, General anaesthesia, Neurodevelopment, Infants, Neonates
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine sedationDrug
Also called Dex
Patients receive dexmedetomidine sedation
General sevoflurane anaesthesiaDrug
Also called Gas
Patients receive general sevoflurane anaesthesia with endotracheal intubation
Caudal anaesthesiaProcedure or surgery
Also called Caudal
single shot caudal anaesthesia
Inguinal hernia surgeryProcedure or surgery
Also called Inguinal herniotomy
Infant inguinal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Dex Group | Experimental | Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery. Receives: Drug: Dexmedetomidine sedation; Procedure: Caudal anaesthesia; Procedure: 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. Receives: Drug: General sevoflurane anaesthesia; Procedure: Caudal anaesthesia; Procedure: Inguinal hernia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
Bayley scores at 2 years
Bayleys scales of Infant Development version III
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion20 Jul 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisorderStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singhealth Foundation, Institute for Human Development and Potential (IHDP), Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Choon L Bong, MBChB FRCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559102
- Sponsor's protocol ID
- SHF/CTG055/2014
- Acronym
- DEGA
- Status last verified
- Mar 2017
- First submitted
- 4 Aug 2015
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12574416Sanders 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.
PubMed 20003127Mahmoud 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.
PubMed 26170346Bong 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.
PubMed 30916007
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery on Peri-operative Outcomes and Neurocognitive Development in Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02559102
- Acronym / sponsor ID
- DEGA / SHF/CTG055/2014
- Keywords
- Dexmedetomidine sedation, General anaesthesia, Neurodevelopment, Infants, Neonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singhealth Foundation, Institute for Human Development and Potential (IHDP), Singapore, Duke-NUS Graduate Medical School
- Study start
- Jul 2015
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex Group | Experimental | Drug: Dexmedetomidine sedation, Procedure: Caudal anaesthesia, Procedure: Inguinal hernia surgeryIntravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery. |
| GA Group | Active comparator | Drug: General sevoflurane anaesthesia, Procedure: Caudal anaesthesia, Procedure: Inguinal hernia surgeryGeneral 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. |
Who may qualify
- Ages
- 34 to 54 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine sedationAlso: DexPatients receive dexmedetomidine sedation | Drug | Dex Group |
| General sevoflurane anaesthesiaAlso: GasPatients receive general sevoflurane anaesthesia with endotracheal intubation | Drug | GA Group |
| Caudal anaesthesiaAlso: Caudalsingle shot caudal anaesthesia | Procedure or surgery | Dex Group, GA Group |
| Inguinal hernia surgeryAlso: Inguinal herniotomyInfant inguinal hernia repair. | Procedure or surgery | Dex Group, GA Group |
Primary outcome
Deferred Imitation scores at 6 months
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).
1 secondary outcome
Bayley scores at 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 12574416Jevtovic-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.
- Background: PubMed 20003127Sanders 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.
- Background: PubMed 26170346Mahmoud 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.
- Derived from this study: PubMed 30916007Bong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon L Bong, MBChB FRCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine sedation, General sevoflurane anaesthesia and Caudal anaesthesia in people with Neurodevelopmental Disorder and Bilateral Inguinal Hernia, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deferred Imitation scores at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559102, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.