IMP will be used to provide conscious sedation for healthy volunteers. No medical condition
Conditions
Interventions
Trade Name: Diprivan 1%
Product Name: Propofol
Pharmaceutical Form: Intravenous infusion
Sponsors
Greater Glasgow Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA I or II (healthy or mild systemic illness) healthy volunteers. Age 18 - 50 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: 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 small potential for over sedation in a group of healthy volunteers.;Secondary Objective: To assess volunteer satisfaction.;Primary end point(s): 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