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

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00848861
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

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
Active Comparator: 1 propofol Drug: propofol (sedation for outpatient colonoscopy)
Active Comparator: 2 midazolam plus meperidine 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on August 28, 2014