Status:
UNKNOWN
Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients
Lead Sponsor:
University of Glasgow
Collaborating Sponsors:
Equity Partners (University Challenge Fund)
Conditions:
Oral Surgical Procedures
Surgery, Oral
Eligibility:
All Genders
18-65 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) undergoing planned dental surgery or colonoscopy.
- Age 18 - 65
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 :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00355693
Start Date
October 1 2006
End Date
February 1 2007
Last Update
August 24 2006
Active Locations (2)
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1
Glasgow Dental Hospital and School
Glasgow, Glasgow, United Kingdom, G2 3JZ
2
Duncan Street Dental Centre
Edinburgh, United Kingdom, EH9 1SR