A Trial Comparing Propofol to Midazolam Plus Meperidine Sedation for Outpatient Colonoscopy
Condition: Sedation
Study type: Interventional

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

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.
    

Intervention name(s): propofol (sedation for outpatient colonoscopy); midazolam plus meperidine (sedation for outpatient colonoscopy)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam; Meperidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: propofol sedation; colonoscopy; recovery time; recovery time after sedation for colonoscopy