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

This study has been completed.
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Sonia Allam, University of Glasgow
ClinicalTrials.gov Identifier:
First received: May 1, 2006
Last updated: February 4, 2012
Last verified: February 2012

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
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:

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


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

United Kingdom
Glasgow Dental Hospital
Glasgow, Strathclyde, United Kingdom
Sponsors and Collaborators
Sonia Allam
NHS Greater Glasgow and Clyde
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:

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, General
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 April 23, 2014