Randomised clinical trial of the effects of Total Intravenous Anaesthesia (TIVA: propofol) versus volatile anaesthesia (sevoflurane-nitrous oxide) on children's post-operative cognition, behaviour and physical morbidity
| ISRCTN | ISRCTN33376683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33376683 |
| Protocol serial number | CZH/4/382 |
| Sponsor | NHS Glasgow and Clyde/University of Glasgow |
| Funder | Chief Scientist Office of the Scottish Executive Health Department (UK) (Grant ref: CZH/4/382) |
- Submission date
- 12/03/2007
- Registration date
- 30/04/2007
- Last edited
- 18/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Keith Millar
Scientific
Scientific
Section of Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
| Phone | +44 (0)141 211 3939 |
|---|---|
| k.millar@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single centre clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised clinical trial of the effects of Total Intravenous Anaesthesia (TIVA: propofol) versus volatile anaesthesia (sevoflurane-nitrous oxide) on children's post-operative cognition, behaviour and physical morbidity |
| Study objectives | Recovery of children's cognitive function will be quicker, and physical morbidity less, after intravenous compared to volatile anaesthesia. |
| Ethics approval(s) | West Ethics Committee of the Western Infirmary, 09/01/2007, ref: 07S07033 |
| Health condition(s) or problem(s) studied | Dental caries |
| Intervention | Children will be randomised to separate groups having general anaesthesia with the intravenous agent propofol, or the volatile agent sevoflurane-nitrous oxide. They will perform child-appropriate tests of reaction time, motor control, attention and memory pre-operatively (baseline), post-operatively prior to discharge, and 48 hours later at home. Between-group comparisons of performance and of post-operative physical morbidity will test the hypothesis stated above. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sevoflurane-nitrous oxide and propofol |
| Primary outcome measure(s) |
Cognitive performance on tests of reaction time, motor control, attention and memory. |
| Key secondary outcome measure(s) |
Physical morbidity assessed by day-surgery staff using a standard protocol at discharge. |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 360 |
| Key inclusion criteria | 1. Male and female children aged seven to 12 years 2. American Society of Anaesthesiologists (ASA) grade I or II 3. Requiring general anaesthesia for multiple dental extractions |
| Key exclusion criteria | 1. Respiratory disorder 2. Learning disability 3. Non-fluent English 4. Neurological or psychological impairments that would impede cognitive assessment |
| Date of first enrolment | 19/03/2007 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Section of Psychological Medicine
Glasgow
G12 0XH
United Kingdom
G12 0XH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/04/2016: No publications found, verifying study status with principal investigator
