NCT00321360

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 small potential for over sedation in a group of healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

May 1, 2006

Last Update Submit

February 4, 2012

Conditions

Healthy

Keywords

propofolsedation

Outcome Measures

Primary Outcomes (2)

  • Minimal Sedation Level obtained (modified Objective Observer's Assessment of Sedation)

  • Maximal change in oxygen saturation (SpO2)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

PropofolDRUG
Patient maintained sedationDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Dental Hospital

Glasgow, Strathclyde, United Kingdom

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sonia Allam, MB ChB FRCA

    University of Glasgow Dept of Anaesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Fellow in Anaesthesia

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

GB(1)