Drug Safety Clinical Trial
Official title:
Phase 4, Prospective, Randomized, Double-blinded, Placebo-controlled Study Comparing Propofol vs. Midazolam Plus Propofol for Nonanesthesiologist Targeted Moderate Sedation in Outpatient Colonoscopy
Nonanesthesiologist administration of propofol for sedation is actually a field of growing
interest for endoscopists, as demonstrated by recent American and European guidelines on
this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a
single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation
(BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be
successfully titrated to moderate sedation. However, nonanesthesiologists propofol
administration remains controversial on account of the possibility of deep sedation/general
anesthesia related adverse events. On the other hand, the use of longer elimination
half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and
recovery.
Up to date, no study has addressed a head-to-head comparison of both regimens administered
by non-anesthesiologists and titrated to moderate sedation.
This study aims to evaluate the impact on propofol sedation of premedication with a fixed
dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate
sedation, in terms of depth of sedation, recovery times, safety and satisfaction.
The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak
effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts
a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam
may increase the depth of sedation through the initial phases of the procedure, diminishing
propofol requirements, but not prolonging significantly recovery times.
Justification of the study:
Nonanesthesiologist administration of propofol is controversial owing to deep sedation
concerns. One of the latest therapeutic innovations on this issue has been the development
of balanced propofol sedation, which consists of adding low doses of opioids or
benzodiazepins. Several studies have recently demonstrated that BPS allows successfully
moderate sedation, maintains a reversible drug component, reduces the total dose of propofol
even by more than 50% without increasing adverse events and maintains high levels of
physician and patient satisfaction, even for advanced endoscopic procedure. However,
recovery may be prolonged by using midazolam or meperidine as they have a longer elimination
half-life than propofol has.
Up to date, nonanesthesiologist administration of propofol and BPS, using either midazolam
or fentanyl, for outpatient colonoscopy have been compared in a single non-placebo
controlled randomized trial (VanNatta and Rex, 2006). In this study, the authors obtained
shorter recovery times with BPS compared to propofol alone, in contrast with the expected on
account of pharmacokinetics. These results can be easily understood yet single-agent
propofol was titrated to deep sedation, whereas BPS was titrated to moderate sedation.
Therefore, it is necessary to make a randomized, double-blinded, placebo-controlled trial to
directly compare both sedation regimens targeted to a similar moderate level of sedation.
The results of this study will conclude which should be the first line treatment for
moderate sedation in colonoscopy, providing further insight in drug synergy and its impact
on the depth of sedation and recovery times
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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