Effect site controlled, reaction time safeguarded, patient maintained sedation with propofol in Healthy Volunteers - Patient maintained sedation with propofol in healthy volunteers.
- Conditions
- IMP will be used to provide conscious sedation for healthy volunteers.No medical condition
- Registration Number
- EUCTR2005-005443-26-GB
- Lead Sponsor
- Greater Glasgow Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method