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

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

Detailed Description
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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.

Conditions
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Sedation

Intervention / Treatment
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* Drug: propofol (sedation for outpatient colonoscopy)
* Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 propofol<br> | Drug: propofol (sedation for outpatient colonoscopy)<br> <br> |
| Active Comparator: 2 midazolam plus meperidine<br> | Drug: midazolam plus meperidine (sedation for outpatient colonoscopy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time |  |  | 
| patient satisfaction |  |  | 
| adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol sedation, colonoscopy, recovery time, recovery time after sedation for colonoscopy