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Sponsored by: |
University of Alberta |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00848861 |
Condition | Intervention |
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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 |
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 |
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1 propofol: Active Comparator | Drug: propofol (sedation for outpatient colonoscopy) |
2 midazolam plus meperidine: Active Comparator | Drug: midazolam plus meperidine (sedation for outpatient colonoscopy) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada |
Principal Investigator: | Dina Kao, MD | University of Alberta |
Principal Investigator: | Eoin Lalor | University of Alberta |
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 |
propofol sedation colonoscopy recovery time recovery time after sedation for colonoscopy |
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 |
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 |