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A Trial Comparing Propofol to Midazolam Plus Meperidine Sedation for Outpatient Colonoscopy
This study has been completed.
First Received: February 19, 2009   No Changes Posted
Sponsored by: University of Alberta
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00848861
  Purpose
  • to determine if propofol sedation leads to shorter recovery times compared to traditional sedation using midazolam plus meperidine

Condition Intervention
Sedation
Drug: propofol (sedation for outpatient colonoscopy)
Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)

Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • recovery time [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • procedure time [ Designated as safety issue: No ]
  • patient satisfaction [ Designated as safety issue: No ]
  • adverse events [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: February 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 propofol: Active Comparator Drug: propofol (sedation for outpatient colonoscopy)
2 midazolam plus meperidine: Active Comparator Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848861

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

Publications:
Responsible Party: University of Alberta ( Dina Kao )
Study ID Numbers: 2-kao
Study First Received: February 19, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00848861     History of Changes
Health Authority: Canada: Ethics Review Committee

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

Study placed in the following topic categories:
Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Adjuvants, Immunologic
Psychotropic Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Midazolam
Meperidine
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Propofol
Analgesics, Opioid

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

ClinicalTrials.gov processed this record on August 30, 2009