Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy
Condition: Colonoscopy
Intervention: Dexmedetomidine; Saline placebo; Propofol
Intervention description: Dexmedetomidine 0.3 ug/kg intravenous bolus; Intravenous saline/placebo; Propofol titrated intravenous boluses
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An ideal sedative for colonoscopy should have properties that include: rapid onset and offset
      of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for
      smooth recovery, and early discharge. Propofol is often used solely because of its rapid
      onset and short duration of action---a property which is ideal for a fast recovery and early
      discharge in the ambulatory setting. However, the use of propofol has been associated with
      undesirable effects such as hypotension, hypoventilation and apnea requiring assisted
      ventilation.

      Balanced anesthesia, using a combination of medications with different mechanisms of action
      can reduce the total amount of each sedative agent used and minimize their side effects while
      achieving the desired level of sedation. Dexmedetomidine is one agent that has been used
      either alone or in combination with propofol for sedation during colonoscopy. While there are
      many advantages to using dexmedetomidine, there is concern that the use of this agent for
      sedation during colonoscopy may prolong post-operative recovery time and readiness for
      discharge home.

      No study has definitively assessed whether the use of dexmedetomidine in combination with
      propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by
      the Modified Post Anesthesia Discharge Scoring System (MPADSS).
    

Eligibility criteria:

        Inclusion Criteria:

        • patients scheduled to undergo colonoscopy at SUNY Downstate Medical Center.

        Exclusion Criteria:

          -  < 18 years old

          -  > 75 years old

          -  Cognitively Impaired patients (Cognitively impaired patients are excluded from the
             study because our primary outcome involves a very strict discharge criteria that
             requires the patient to respond to and perform tasks on our pre-existing discharge
             scale checklist. These may be impossible to assess or will be difficult to standardize
             for patients whom are Cognitively Impaired.)

          -  Pregnant patients

          -  Patients who use a wheelchair or ambulates with crutches (Patients using a wheelchair
             are excluded from the study because our primary outcome involves a very strict
             discharge criteria that requires the patient to respond to and perform tasks on our
             pre-existing discharge scale checklist. These may be impossible to assess or will be
             difficult to standardize for patients whom who use a wheel-chair).

          -  Limited exercise tolerance (as this could represent active coronary disease)

          -  Total body weight greater than 105 kg (due to maximal dose of drug available in
             randomized syringes containing study drug)

          -  Propofol, soy, glycerol or dexmedetomidine allergy

          -  Significant renal impairment

          -  Significant hepatic impairment

          -  Inability to read or write in English