Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients

This study is not yet open for participant recruitment.

Verified by University of Glasgow, April 2006

Sponsors and Collaborators:	University of Glasgow Equity Partners (University Challenge Fund)
Information provided by:	University of Glasgow
ClinicalTrials.gov Identifier:	NCT00355693

Purpose

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 over sedation in a groups of patients undergoing oral surgery, general dentistry and colonoscopy.

Condition	Intervention	Phase
Oral Surgical Procedures Surgery, Oral Dental Anxiety Surgery Colonoscopy	Device: Pump for propofol delivery	Phase IV

MedlinePlus related topics: Anxiety

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol A) in Oral Surgery Patients B) in General Dentistry Patients C) in Colonoscopy Patients

Further study details as provided by University of Glasgow:

Primary Outcome Measures:

Minimal Sedation Level obtained (modified Objective Observers's Assessment of Sedation)
(Scores 5, fully awake to 1, unresponsive)
Maximal change in oxygen saturation (SpO2)

Secondary Outcome Measures:

Effect site concentrations of propofol
Anxiety Levels
Requirement for supplementary oxygen (if SpO2 < 90%)
Requirement for airway support
Maximal change in heart rate (HR) and blood pressure (BP)
Operator assessment (ease of procedure, cooperation)
Patient Satisfaction and recollection

Estimated Enrollment:	60
Study Start Date:	October 2006
Estimated Study Completion Date:	February 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA I or II (healthy or mild systemic illness) undergoing planned dental surgery or colonoscopy.
Age 18 - 65

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 or breastfeeding
Unable or unwilling to give informed consent
Unable to use necessary apparatus
Vulnerable groups

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355693

Contacts

Contact: Sonia Allam, MB ChB FRCA	0141 211 4625	soniaallam@yahoo.com
Contact: Conor P O'Brien, BDS FDS	0141 211 9768 ext 89768	Conor.O'Brien@NorthGlasgow.Scot.NHS.UK

Locations

United Kingdom
Duncan Street Dental Centre
Edinburgh, United Kingdom, EH9 1SR
Glasgow Dental Hospital and School
Glasgow, United Kingdom, G2 3JZ

Sponsors and Collaborators

University of Glasgow

Equity Partners (University Challenge Fund)

Investigators

Principal Investigator:	Sonia Allam, MB ChB FRCA	University of Glasgow Dept of Anaesthesia
Principal Investigator:	Conor P O'Brien, BDS FDS	Glasgow Dental Hospital & School
Principal Investigator:	Avril Macpherson, MFDS MSND	NHS Lothian

More Information

Study ID Numbers:	9812/A
Study First Received:	July 21, 2006
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00355693
Health Authority:	Scotland: Central Office of Research and ethics Committee

Keywords provided by University of Glasgow:

Anxiety
Dental
Oral
Surgery
Colonoscopy

Propofol
Sedation
Effect
Reaction

Study placed in the following topic categories:

Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009