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

This study has been completed.
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Sonia Allam, University of Glasgow
ClinicalTrials.gov Identifier:
NCT00321360
First received: May 1, 2006
Last updated: February 4, 2012
Last verified: February 2012
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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reaction Time Monitored Patient Maintained Propofol Sedation: a Volunteer Safety Study

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
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 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sonia Allam, Research Fellow in Anaesthesia, University of Glasgow
ClinicalTrials.gov Identifier: NCT00321360     History of Changes
Other Study ID Numbers: 9813
Study First Received: May 1, 2006
Last Updated: February 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:
propofol
sedation

Additional relevant MeSH terms:
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