Condition category
Oral Health
Date applied
12/03/2007
Date assigned
30/04/2007
Last edited
18/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Millar

ORCID ID

Contact details

Section of Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3939
k.millar@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/382

Study information

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

Acronym

Study hypothesis

Recovery of children's cognitive function will be quicker, and physical morbidity less, after intravenous compared to volatile anaesthesia.

Ethics approval

West Ethics Committee of the Western Infirmary, 09/01/2007, ref: 07S07033

Study design

Randomised single centre clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Sevoflurane-nitrous oxide and propofol

Primary outcome measures

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 trial start date

19/03/2007

Overall trial end date

28/02/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Respiratory disorder
2. Learning disability
3. Non-fluent English
4. Neurological or psychological impairments that would impede cognitive assessment

Recruitment start date

19/03/2007

Recruitment end date

28/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

NHS Glasgow and Clyde/University of Glasgow

Sponsor details

Research and Development Office
NHS Glasgow and Clyde
Yorkhill Hospital
Dalnair Street
Glasgow
G3 8SJ
United Kingdom
+44 (0)141 201 0005
alison.wood@yorkhill.scot.nhs.uk

Sponsor type

Government

Website

http://www.nhsgg.org.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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