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Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00321360
First Posted: May 3, 2006
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Sonia Allam, University of Glasgow
  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 small potential for over sedation in a group of healthy volunteers.

Condition Intervention Phase
Healthy Drug: Propofol Device: Patient maintained sedation Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reaction Time Monitored Patient Maintained Propofol Sedation: a Volunteer Safety Study

Resource links provided by NLM:


Further study details as provided by Sonia Allam, University of Glasgow:

Primary Outcome Measures:
  • Minimal Sedation Level obtained (modified Objective Observer's Assessment of Sedation)
  • Maximal change in oxygen saturation (SpO2)

Secondary Outcome Measures:
  • The maximal effect site concentration of propofol at which the minimal sedation level and maximal change in oxygen saturation were achieved
  • Relationship between reaction time, sedation level and effect site concentration of propofol
  • Requirement for supplementary oxygen (if SpO2 < 90%)
  • Requirement for airway or ventilatory support
  • Maximal change in heart rate (HR), respiratory rate (RR) and blood pressure (BP)
  • Volunteer satisfaction and recollection

Estimated Enrollment: 20
Study Start Date: May 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I or II (healthy or mild systemic illness) healthy volunteers
  • Age 18 - 50

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
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): NCT00321360


Locations
United Kingdom
Glasgow Dental Hospital
Glasgow, Strathclyde, United Kingdom
Sponsors and Collaborators
Sonia Allam
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Sonia Allam, MB ChB FRCA University of Glasgow Dept of Anaesthesia
  More Information

Responsible Party: Sonia Allam, Research Fellow in Anaesthesia, University of Glasgow
ClinicalTrials.gov Identifier: NCT00321360     History of Changes
Other Study ID Numbers: 9813
First Submitted: May 1, 2006
First Posted: May 3, 2006
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Sonia Allam, University of Glasgow:
propofol
sedation

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