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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by University of Glasgow.
Recruitment status was:  Not yet recruiting
Equity Partners (University Challenge Fund)
Information provided by:
University of Glasgow Identifier:
First received: July 21, 2006
Last updated: August 23, 2006
Last verified: April 2006
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
Device: Pump for propofol delivery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00355693

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)
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 Identifier: NCT00355693     History of Changes
Other Study ID Numbers: 9812/A 
Study First Received: July 21, 2006
Last Updated: August 23, 2006

Keywords provided by University of Glasgow:

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on February 20, 2017