Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy
Condition: Colonoscopy
Intervention: Remimazolam; Midazolam; Placebo
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A prospective, double-blind, randomized, placebo and active controlled, multi-center,
      parallel group study comparing remimazolam to placebo, with an additional open-label arm for
      midazolam, in American Society of Anesthesiologists (ASA) Grade III and IV patients (ASA
      status evaluated by an anesthesiologist not otherwise involved in the study) undergoing a
      colonoscopy for diagnostic or therapeutic reasons.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic
             colonoscopy (therapeutic procedures may include hemostasis, resection, ablation
             decompression, and foreign body extraction, for example).

          2. ASA grade III/IV

               1. ASA III patients are patients with severe systemic disease eg patients who, in
                  the judgment of the Principal Investigator (PI), have significant enough systemic
                  disease to warrant performing the colonoscopy procedure only in a facility which
                  has post-procedure inpatient capability. ASA III physical status classification
                  encompasses a wide range of potential patient co-morbidities some of which may
                  make the selection of a facility with post-procedure inpatient capability
                  preferable. By definition, ASA III patients have one or more moderate to severe
                  systemic diseases which potentially cause substantial functional limitation.
                  Examples may include poorly controlled diabetes or hypertension, moderate to
                  severe chronic obstructive pulmonary disease, active hepatitis, heart failure or
                  coronary artery disease (including implanted pacemaker and/or stent, recent
                  myocardial infarction) cerebrovascular accident, or end stage renal disease
                  requiring dialysis.

               2. ASA IV patients are patients with severe systemic disease that is a constant
                  threat to life eg at least one severe disease that is poorly controlled or at end
                  stage; possible risk of death; unstable angina; symptomatic chronic obstructive
                  pulmonary disease; symptomatic chronic heart failure; hepatorenal failure.

          3. For all female patients, negative result of urine or serum pregnancy test.
             Additionally, for women with child-bearing potential only, use of birth control during
             the study period (from the time of consent until all specified observations are
             completed).

          4. Patient voluntarily signs and dates an informed consent form (ICF) that is approved by
             an investigational review board (IRB) prior to the conduct of any study procedure.

          5. Patient is willing and able to comply with study requirements and will be available
             for a Follow-up Visit on Day 1 (+ 1 day) and Follow-up Phone call (Day 4 +/- 3 days)
             after the colonoscopy.

        Exclusion Criteria:

          1. Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone,
             or a medical condition such that these agents are contraindicated.

          2. Female patients with a positive pregnancy test at screening or baseline and lactating
             female patients.

          3. Patients clearly acutely intoxicated with alcohol or drugs of abuse at baseline.

          4. Patients in receipt of any investigational drug within 30 days or less than 7
             half-lives (whichever is longer) before Screening, or scheduled to receive one during
             the study period.

          5. Participation in any previous clinical trial with remimazolam.

          6. Patients with an inability to communicate well with the Investigator, or deemed
             unsuitable according to the Investigator (in each case providing a reason).