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

NCT03139279 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB: 932304
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure

  Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.

  30 minutes

Secondary Outcomes (4)

• Average Total Propofol Consumption Per Group

  between 7 and 57 minutes (median 19 min)

• Number of Participants With Sustained Bradycardic Episodes

  30 minutes

• Lowest Intraoperative % Change in MAP From Baseline

  30 minutes

• Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation

  30 minutes

Study Arms (2)

Dexmedetomidine and propofol

EXPERIMENTAL

Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.

Drug: Dexmedetomidine; Drug: Propofol

Saline placebo and propofol

PLACEBO COMPARATOR

Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.

Other: Saline placebo; Drug: Propofol

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 0.3 ug/kg intravenous bolus

Also known as: Dex, Precedex

Dexmedetomidine and propofol

Saline placebo OTHER

Intravenous saline/placebo

Saline placebo and propofol

Propofol DRUG

Propofol titrated intravenous boluses

Also known as: Diprivan

Dexmedetomidine and propofol; Saline placebo and propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo colonoscopy at SUNY Downstate Medical Center.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related Publications (12)

• Vicari JJ. Sedation and analgesia. Gastrointest Endosc Clin N Am. 2002 Apr;12(2):297-311, viii. doi: 10.1016/s1052-5157(01)00011-3.

  PMID: 12180162 BACKGROUND

• Faigel DO, Baron TH, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Peterson KA, Waring JP, Fanelli RD, Wheeler-Harbaugh J; Standards Practice Committe, American Society for Gastrointestinal Endoscopy. Guidelines for the use of deep sedation and anesthesia for GI endoscopy. Gastrointest Endosc. 2002 Nov;56(5):613-7. doi: 10.1016/s0016-5107(02)70104-1. No abstract available.

  PMID: 12397263 BACKGROUND

• Waring JP, Baron TH, Hirota WK, Goldstein JL, Jacobson BC, Leighton JA, Mallery JS, Faigel DO; American Society for Gastrointestinal Endoscopy, Standards of Practice Committee. Guidelines for conscious sedation and monitoring during gastrointestinal endoscopy. Gastrointest Endosc. 2003 Sep;58(3):317-22. doi: 10.1067/s0016-5107(03)00001-4.

  PMID: 14528201 BACKGROUND

• Akarsu Ayazoglu T, Polat E, Bolat C, Yasar NF, Duman U, Akbulut S, Yol S. Comparison of propofol-based sedation regimens administered during colonoscopy. Rev Med Chil. 2013 Apr;141(4):477-85. doi: 10.4067/S0034-98872013000400009.

  PMID: 23900369 BACKGROUND

• Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.

  PMID: 25801162 BACKGROUND

• Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.

  PMID: 11046225 BACKGROUND

• Taittonen MT, Kirvela OA, Aantaa R, Kanto JH. Effect of clonidine and dexmedetomidine premedication on perioperative oxygen consumption and haemodynamic state. Br J Anaesth. 1997 Apr;78(4):400-6. doi: 10.1093/bja/78.4.400.

  PMID: 9135361 BACKGROUND

• Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.

  PMID: 12145072 BACKGROUND

• Jalowiecki P, Rudner R, Gonciarz M, Kawecki P, Petelenz M, Dziurdzik P. Sole use of dexmedetomidine has limited utility for conscious sedation during outpatient colonoscopy. Anesthesiology. 2005 Aug;103(2):269-73. doi: 10.1097/00000542-200508000-00009.

  PMID: 16052108 BACKGROUND

• Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, Dagli G. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol. 2010 Jul;27(7):648-52. doi: 10.1097/EJA.0b013e3283347bfe.

  PMID: 20531094 BACKGROUND

• Palumbo P, Tellan G, Perotti B, Pacile MA, Vietri F, Illuminati G. Modified PADSS (Post Anaesthetic Discharge Scoring System) for monitoring outpatients discharge. Ann Ital Chir. 2013 Nov-Dec;84(6):661-5.

  PMID: 23165318 BACKGROUND

• Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.

  PMID: 5534693 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dennis Dimaculangan, MD
• Organization: Department of Anesthesiology, SUNY Downstate Medical Center

dennis.dimaculangan@downstate.edu

718-270-3765

Study Officials

• Dennis Dimaculangan, MD

  SUNY Downstate Medical Center Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: May 5, 2017
• Primary Completion: May 4, 2018
• Study Completion: July 19, 2018
• Last Updated: July 29, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)