Dental caries MedDRA version: 8.1 Level: LLT Classification code 10012318 Term: Dental caries
Conditions
Interventions
Trade Name: Propofol-Lipuro 1%
Product Name: Propofol
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: PROPOFOL
CAS Number
Sponsors
NHS Glasgow and Clyde / University of Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed