NCT00614263

Brief Summary

Examine levels of sedation required for patients to comfortably undergo colonoscopy using propofol and if adjunct monitoring equipment promotes patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

January 31, 2008

Last Update Submit

June 9, 2017

Conditions

Outpatient Colonoscopy

Keywords

ColonoscopySedation levels

Outcome Measures

Primary Outcomes (1)

  • Examine possible relationships (correlations) between sedation using the SEDLine monitors and level of sedation using the Ramsay Sedation Scale and examine the number and type of airway interventions and clinical signs performed during the procedure.

    2 years

Study Arms (2)

Blinded Group

SEDline output is unknown to anesthesiologist.

Unblinded Group

SEDline output is known to anesthesiologist.

Eligibility Criteria

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

Outpatient GI clinic

You may qualify if:

  • Greater than 18 years of age
  • ASA classification of I, II, or III

You may not qualify if:

  • Anesthesiologist plans to use a combination of medications other than propofol for sedation.
  • ASA classification IV or higher
  • Lesions on forehead or earlobes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center - Department of Anesthesiology

Dallas, Texas, 75246, United States

Location

Study Officials

  • Michael Ramsay, MD

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

US(1)