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

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ClinicalTrials.gov Identifier: NCT00355693
Recruitment Status : Unknown
Verified April 2006 by University of Glasgow.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2006
Last Update Posted : August 24, 2006
Sponsor:
Collaborator:
Equity Partners (University Challenge Fund)
Information provided by:
University of Glasgow

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 time as an added safeguard against the potential for over sedation in a groups of patients undergoing oral surgery, general dentistry and colonoscopy.

Condition or disease Intervention/treatment Phase
Oral Surgical Procedures Surgery, Oral Dental Anxiety Surgery Colonoscopy Device: Pump for propofol delivery Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Propofol
U.S. FDA Resources




Primary Outcome Measures :
  1. Minimal Sedation Level obtained (modified Objective Observers's Assessment of Sedation)
  2. (Scores 5, fully awake to 1, unresponsive)
  3. Maximal change in oxygen saturation (SpO2)

Secondary Outcome Measures :
  1. Effect site concentrations of propofol
  2. Anxiety Levels
  3. Requirement for supplementary oxygen (if SpO2 < 90%)
  4. Requirement for airway support
  5. Maximal change in heart rate (HR) and blood pressure (BP)
  6. Operator assessment (ease of procedure, cooperation)
  7. Patient Satisfaction and recollection


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00355693     History of Changes
Other Study ID Numbers: 9812/A
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: August 24, 2006
Last Verified: April 2006

Keywords provided by University of Glasgow:
Anxiety
Dental
Oral
Surgery
Colonoscopy
Propofol
Sedation
Effect
Reaction

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics