No specific medical condition. IMP will be used to provide conscious sedation for patients undergoing potentially unpleasant procedures including dentistry and colonoscopy.
Conditions
Interventions
Trade Name: Diprivan
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Propofol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Sponsors
Greater Glasgow Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA I or II (healthy or mild systemic illness) undergoing planned dental surgery or colonoscopy. Age 18 - 65 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: ASA III or above Out with age group above Contraindication to propofol History of epilepsy History of substance abuse Major Psychiatric illness Pregnancy Unable or unwilling to give informed consent Unable to use necessary apparatus Vulnerable groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether patient-maintained sedation (the patient controls his/her degree of sedation using a hand-held device) using the drug propofol is safer and more effective when using deteriorating reaction time as an added safeguard against the potential for oversedation in groups of patients undergoing dental surgery and colonoscopy.;Secondary Objective: To assess patient and operator satisfaction.;Primary end point(s): Physiological - Maximal change in Oxygen Saturation (SpO2), Respiratory Rate (RR) and Maximal Sedation Level obtained (modified Objective Observers's Assessment of Sedation) | — |
Countries
United Kingdom
Outcome results
None listed