A Trial Comparing Propofol to Midazolam Plus Meperidine Sedation for Outpatient Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848861
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Information provided by:
University of Alberta

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

Condition or disease Intervention/treatment Phase
Sedation Drug: propofol (sedation for outpatient colonoscopy) Drug: midazolam plus meperidine (sedation for outpatient colonoscopy) Not Applicable

Detailed Description:

Colonoscopy is an important diagnostic and therapeutic procedure. It is an invasive procedure, not well tolerated by most patients if performed without sedation. There is considerable variability in the practice of sedation for endoscopic procedures worldwide. There are some centers which perform a significant proportion of gastroscopies and colonoscopies without sedation. On the other hand, general anesthesia is given to more than 90% of patients undergoing colonoscopy in France. Most centers do use conscious sedation, usually in the form of benzodiazepines and/or narcotics, with propofol sedation reserved for difficult cases. Benzodiazepines and narcotics are effective and safe. However, the onset of sedation can be delayed, and in some patients conscious sedation is inadequate, resulting in a poor experience with the procedure. Moreover, there are significant post-sedation side effects, such as nausea, vomiting, and prolonged recovery period. This can substantially increase procedure costs due to the need for prolonged monitoring after endoscopy.

Propofol, a general anesthetic agent, has been routinely used in various procedures and surgeries. It has a fast onset of action (within 30-60 seconds), a short half life (1.8-4.1 minutes) but a narrow therapeutic window. The current package insert of propofol states that only persons trained in the administration of general anesthesia should administer propofol and these physicians should not be involved in the procedure so that patients can be continuously and properly monitored due to the risk of respiratory depression. No deaths associated with propofol sedation have been reported since it was first introduced in gastrointestinal endoscopy in the mid 1980. However, need for mechanical ventilation as a result of propofol sedation has been reported. In a number of small trials propofol was shown to have a superior recovery profile following various endoscopic procedures including gastroscopy, colonoscopy and endoscopic retrograde cholangiopancreatography (ERCP). Indeed, propofol sedation is now used routinely in elective adult procedures in some centers. However, the lower cost of recovery is offset by the need for an anesthesiologist. Therefore, the use of propofol sedation is limited to selected endoscopic procedures or patients.

Although a number of small randomized trials have explored the efficacy of propofol sedation, the evidence is not definitive. Thus we conducted this study to determine if propofol sedation leads to shorter recovery times in elective outpatient colonoscopy compared to usual care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : February 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 propofol Drug: propofol (sedation for outpatient colonoscopy)
Active Comparator: 2 midazolam plus meperidine Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)

Primary Outcome Measures :
  1. recovery time

Secondary Outcome Measures :
  1. procedure time
  2. patient satisfaction
  3. adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • outpatient colonoscopy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848861

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Principal Investigator: Dina Kao, MD University of Alberta
Principal Investigator: Eoin Lalor University of Alberta

Responsible Party: Dina Kao, University of Alberta Identifier: NCT00848861     History of Changes
Other Study ID Numbers: 2-kao
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by University of Alberta:
propofol sedation
recovery time
recovery time after sedation for colonoscopy

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents