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

• Status: Completed
• Trial end date: 2018-07-19
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: State University of New York - Downstate Medical Center
• Treatments: Dexmedetomidine; Propofol

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