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.

INTERVENTION: 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‐ CONDITION: Dental caries ; MedDRA version: 8.1 Level: LLT Classification code 10012318 Term: Dental caries PRIMARY OUTCOME: 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. 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. 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 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