NCT00355693

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

August 24, 2006

Status Verified

April 1, 2006

First QC Date

July 21, 2006

Last Update Submit

August 23, 2006

Conditions

Oral Surgical ProceduresSurgery, OralDental AnxietySurgeryColonoscopy

Keywords

AnxietyDentalOralSurgeryColonoscopyPropofolSedationEffectReaction

Outcome Measures

Primary Outcomes (3)

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

  • (Scores 5, fully awake to 1, unresponsive)

  • Maximal change in oxygen saturation (SpO2)

Secondary Outcomes (7)

  • Effect site concentrations of propofol

  • Anxiety Levels

  • Requirement for supplementary oxygen (if SpO2 < 90%)

  • Requirement for airway support

  • Maximal change in heart rate (HR) and blood pressure (BP)

  • +2 more secondary outcomes

Interventions

Pump for propofol deliveryDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II (healthy or mild systemic illness) undergoing planned dental surgery or colonoscopy.
  • Age 18 - 65

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 (2)

Glasgow Dental Hospital and School

Glasgow, Glasgow, G2 3JZ, United Kingdom

Location

Duncan Street Dental Centre

Edinburgh, EH9 1SR, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Allam, MB ChB FRCA

CONTACT

0141 211 4625soniaallam@yahoo.com

Conor P O'Brien, BDS FDS

CONTACT

0141 211 9768Conor.O'Brien@NorthGlasgow.Scot.NHS.UK

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 24, 2006

Study Start

October 1, 2006

Study Completion

February 1, 2007

Last Updated

August 24, 2006

Record last verified: 2006-04

Locations

GB(2)