Randomised clinical trial of the effects of total intravenous anaesthesia (TIVA: propofol) versus volatile anaesthesia (sevoflurane-N20 induction and isoflurane-N20 maintenance) on children’s post-operative cognition, behaviour and physical morbidity. - Cognition GA Study

Phase 1

• Conditions: Dental caries; MedDRA version: 8.1 Level: LLT Classification code 10012318 Term: Dental caries

• Registration Number: EUCTR2006-005742-37-GB
• Lead Sponsor: HS Glasgow and Clyde / University of Glasgow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-02
• Study Completion: 2010-05-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

Male and female children aged 5 - 14 years
Require general anaesthesia for multiple dental extractions and restorations
Fitness ASA class 1 or 2
Written informed consent of parent/ legal guardian
Written assent from child if appropriate
Able to undertake psychometric assessment tests
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

English not first language
Learning disability
Psychiatric condition
ASA fitness class 3 -5
Neurological disorder
Sensory impairment
No consent from parent/legal guardian
Allergy to propofol or it's excipients
Recent general anaesthesia within 3 weeks
Medical comorbidity which would contraindicate general anaesthesia (eg active infection, difficult airway)
Medical comorbidity which would contraindicate use of volatile agents (eg malignant hyperthermia susceptibility)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of cognitive function and emotional well-being after either Total Intravenous Anaesthesia (TIVA) with propofol or volatile anaesthesia with nitrous oxide and sevoflurane induction of anaesthesia followed by nitrous oxide and isoflurane maintenance of anaesthesia.;<br> Secondary Objective: Dose requirements to achieve and maintain a standardised depth of anaesthesia as indicated by auditory evoked potentials.<br> Recovery rate and quality of recovery<br> ;<br> Primary end point(s): Cognitive function assessments: Choice reaction time, Wechsler Intelligence Scale for Children, Rivermead Behavioural Memory Test for Children<br> Behavioural and emotional assessments: Revised Rutter Scale for School-Age Children, Child Impact of Events Scale<br> Assessments are carried out pre-operatively, 1h postoperatively, at 24 hours and at 1 week.<br>