Status:
COMPLETED
Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Healthy Volunteers
Lead Sponsor:
Sonia Allam
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
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 tim...
Detailed Description
Patients receiving conscious sedation for dentistry and endoscopy are usually treated with intermittent bolus doses of intravenous midazolam (administered by the operator-sedationist). The safety of s...
Eligibility Criteria
Inclusion
- ASA I or II (healthy or mild systemic illness) healthy volunteers
- Age 18 - 50
Exclusion
- ASA III or above
- Out with age group above
- Contraindication to propofol
- History of epilepsy
- History of substance abuse
- Major Psychiatric illness
- Pregnancy or breastfeeding
- Unable or unwilling to give informed consent
- Unable to use necessary apparatus
- Vulnerable groups
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00321360
Start Date
May 1 2006
End Date
September 1 2006
Last Update
February 7 2012
Active Locations (1)
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1
Glasgow Dental Hospital
Glasgow, Strathclyde, United Kingdom