Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy

In this study, investigators plan to prospectively compare in a randomized, controlled,
double-blind trial, the sedation technique for colonoscopy between two groups. Group 1:
sedation with dexmedetomidine and propopfol versus group 2: sedation with saline placebo and
propofol.

The study will have the following outcome measures for each group.

Primary outcome measure:

Readiness-for-discharge (RFD) at 10, 20 and 30 minutes after the colonoscopic procedure.
Ready-for-discharge is defined as attainment of MPADSS score of 9-10.

Secondary outcome measures:

1. Total propofol consumption in mg/kg/duration of procedure in minutes;

2. Side effects:

1. lowest intraoperative percent (%) drop in mean arterial pressure (MAP) from
baseline,

2. incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes)
intraoperatively,

3. incidence of apneic episodes intraoperatively requiring positive pressure
ventilation.

Methods:

One hundred patients will be recruited and randomized into two groups. For sedation, Group 1
will receive intravenous dexmedetomidine 0.3 ug/kg bolused at the onset of the procedure
followed by titrated doses of propofol. Group 2 will receive a saline placebo bolus at the
onset of the procedure followed by titrated doses of propofol. A hospital research
pharmacist, based on a randomization table, will allocate to the anesthesia provider giving
the sedation, the bolus syringe labelled dexmedetomidine/or saline study agent. The
anesthesia provider, gastroenterologist, nurses as well as the subject will be blinded as to
the syringe's actual content. A Bispectral Index (BIS) Monitor will be used during sedation.
All subjects will be targeted to maintain a BIS score between 60-70. Outcome measures will be
evaluated for statistical significance in a non-inferiority assessment.

Investigators hypothesize that there will be no difference in the time to discharge between
the two treatment groups.

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