Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy
Condition: Procedural Sedation
Intervention: Midazolam; Propofol
Intervention description: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level; Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Intervention MeSH terms: Midazolam; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Propofol; Midazolam; Moderate sedation; Deep sedation; Colonoscopy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing elective outpatient colonoscopy

        Exclusion Criteria:

          -  Age less than 18 years

          -  Allergy to propofol, soybeans, eggs or midazolam

          -  Chronic intake of benzodiazepines

          -  History of colorectal surgery

          -  ASA class IV, short and tick neck, difficult intubation due to inability to open the
             mouth widely

          -  Pregnancy

          -  Refusal, inability or unwillingness to give written consent

          -  Patients scheduled for advanced therapeutic colonoscopy or for more than one
             endoscopic procedure