NCT00848861

Brief Summary

-to determine if propofol sedation leads to shorter recovery times compared to traditional sedation using midazolam plus meperidine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Shorter than P25 for not_applicable

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

February 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Sedation

Keywords

propofol sedationcolonoscopyrecovery timerecovery time after sedation for colonoscopy

Outcome Measures

Primary Outcomes (1)

  • recovery time

Secondary Outcomes (3)

  • procedure time

  • patient satisfaction

  • adverse events

Study Arms (2)

1 propofol

ACTIVE COMPARATOR
Drug: propofol (sedation for outpatient colonoscopy)

2 midazolam plus meperidine

ACTIVE COMPARATOR
Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)

Interventions

propofol (sedation for outpatient colonoscopy)DRUG
1 propofol
midazolam plus meperidine (sedation for outpatient colonoscopy)DRUG
2 midazolam plus meperidine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatient colonoscopy

You may not qualify if:

  • allergy to propofol , midazolam, meperidine, eggs or soybean
  • history of colonic resection
  • inability to understand spoken/written English
  • dementia
  • pregnancy
  • unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (7)

  • Vijan S, Inadomi J, Hayward RA, Hofer TP, Fendrick AM. Projections of demand and capacity for colonoscopy related to increasing rates of colorectal cancer screening in the United States. Aliment Pharmacol Ther. 2004 Sep 1;20(5):507-15. doi: 10.1111/j.1365-2036.2004.01960.x.

    PMID: 15339322BACKGROUND

  • Trummel J. Sedation for gastrointestinal endoscopy: the changing landscape. Curr Opin Anaesthesiol. 2007 Aug;20(4):359-64. doi: 10.1097/ACO.0b013e32827ab467.

    PMID: 17620846BACKGROUND

  • Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63. doi: 10.1111/j.1572-0241.2005.41672.x.

    PMID: 16128939BACKGROUND

  • Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.

    PMID: 12105827BACKGROUND

  • Kulling D, Fantin AC, Biro P, Bauerfeind P, Fried M. Safer colonoscopy with patient-controlled analgesia and sedation with propofol and alfentanil. Gastrointest Endosc. 2001 Jul;54(1):1-7. doi: 10.1067/mge.2001.116174.

    PMID: 11427833BACKGROUND

  • Lee DW, Chan AC, Sze TS, Ko CW, Poon CM, Chan KC, Sin KS, Chung SC. Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Nov;56(5):629-32. doi: 10.1067/mge.2002.128919.

    PMID: 12397267BACKGROUND

  • Moerman AT, Foubert LA, Herregods LL, Struys MM, De Wolf DJ, De Looze DA, De Vos MM, Mortier EP. Propofol versus remifentanil for monitored anaesthesia care during colonoscopy. Eur J Anaesthesiol. 2003 Jun;20(6):461-6. doi: 10.1017/s0265021503000723.

    PMID: 12803263BACKGROUND

MeSH Terms

Interventions

PropofolMidazolamMeperidine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Dina Kao, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Eoin Lalor

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

February 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

CA(1)