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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 because the information has not been verified recently.
Verified April 2006 by University of Glasgow.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Equity Partners (University Challenge Fund)
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00355693
First received: July 21, 2006
Last updated: August 23, 2006
Last verified: April 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Propofol
U.S. FDA Resources

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 Not yet recruiting
Edinburgh, United Kingdom, EH9 1SR
Contact: Avril Macpherson, BDS, MFDS RCSEd, MSND RCSEd     +44131 667 7114     avril.macpherson@lpct.scot.nhs.uk    
Contact: Francis Arnstein, MB ChB, FRCA     +44131 667 7114     arnie.arnstein@luht.scot.nhs.uk    
Principal Investigator: Avril Macpherson, MFDS MSND            
Sub-Investigator: Francis Arnstein, MB ChB, FRCA            
Glasgow Dental Hospital and School Not yet recruiting
Glasgow, United Kingdom, G2 3JZ
Contact: Conor P O'Brien, BDS FDS     0141 211 9768 ext 9768     Conor.O'Brien@NorthGlasgow.SCOT.NHS.UK    
Contact: Sonia Allam, MB ChB FRCA     0141 211 4625     soniaallam@yahoo.com    
Principal Investigator: Conor P O'Brien, BDS FDS            
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

No publications provided

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 16, 2013