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
Secondary identifying numbers	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

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
Email	k.millar@clinmed.gla.ac.uk

Study information

Study design	Randomised single centre clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sevoflurane-nitrous oxide and propofol
Primary outcome measure	Cognitive performance on tests of reaction time, motor control, attention and memory.
Secondary outcome measures	Physical morbidity assessed by day-surgery staff using a standard protocol at discharge.
Overall study start date	19/03/2007
Completion date	28/02/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	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

Scotland
United Kingdom

Study participating centre

Section of Psychological Medicine

Glasgow
G12 0XH
United Kingdom

Sponsor information

NHS Glasgow and Clyde/University of Glasgow
Government

Research and Development Office
NHS Glasgow and Clyde
Yorkhill Hospital
Dalnair Street
Glasgow
G3 8SJ
United Kingdom

Phone	+44 (0)141 201 0005
Email	alison.wood@yorkhill.scot.nhs.uk
Website	http://www.nhsgg.org.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK) (Grant ref: CZH/4/382)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

18/04/2016: No publications found, verifying study status with principal investigator