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

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) Dental caries MedDRA version: 8.1 Level: LLT Classification code 10012318 Term: Dental caries Trade Name: Propofol-Lipuro 1% Product Name: Propofol Pharmaceutical Form: Intravenous infusion INN or Proposed INN: PROPOFOL CAS Number: 2078548 Concentration unit: % percent Concentration type: equal Concentration number: 1-1 Trade Name: Sevoflurane (Abbott Laboratories Ltd) Product Name: SEVOFLURANE Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: SEVOFLURANE CAS Number: 28523866 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 250-250 Trade Name: Medical Nitrous Oxide Product Name: Medical Nitrous Oxide Pharmaceutical Form: Inhalation gas INN or Proposed INN: NITROUS OXIDE CAS Number: 10024972 Concentration unit: % percent Concentration type: equal Concentration number: 100-100 Trade Name: Isoflurane (Abbott Laboratories Ltd) Product Name: Isoflurane Pharmaceutical Form: Inhalation gas INN or Proposed INN: ISOFLURANE CAS Number: 26675467 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 99.9- 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.; Secondary Objective: Dose requirements to achieve and maintain a standardised depth of anaesthesia as indicated by auditory evoked potentials. Recovery rate and quality of recovery ; Primary end point(s): Cognitive function assessments: Choice reaction time, Wechsler Intelligence Scale for Children, Rivermead Behavioural Memory Test for Children Behavioural and emotional assessments: Revised Rutter Scale for School-Age Children, Child Impact of Events Scale Assessments are carried out pre-operatively, 1h postoperatively, at 24 hours and at 1 week.