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

Colonoscopy Clinical Trial

Official title:

Comparing Time to Readiness for Discharge After Colonoscopy: Propofol and Dexmedetomidine vs Propofol Only Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139279
• Other study ID #: IRB: 932304
• Status: Completed
• Phase: Phase 4
• Start date: May 5, 2017
• Est. completion date: July 19, 2018

Study information

• Verified date: July 2019
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 19, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine 0.3 ug/kg intravenous bolus

Other:
• Saline placebo
Intravenous saline/placebo

Drug:
• Propofol
Propofol titrated intravenous boluses

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. Review. — View Citation

Palumbo P, Tellan G, Perotti B, Pacilè 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. — View Citation

Taittonen MT, Kirvelä 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. — View Citation

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. — View Citation

Vicari JJ. Sedation and analgesia. Gastrointest Endosc Clin N Am. 2002 Apr;12(2):297-311, viii. Review. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average Total Propofol Consumption Per Group	Total propofol consumption per subject was measured as µg/kg/min of procedure in minutes. The average propofol consumption in each group will be measured as secondary outcome.	between 7 and 57 minutes (median 19 min)
Secondary	Number of Participants With Sustained Bradycardic Episodes	Incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes) intraoperatively in each group	30 minutes
Secondary	Lowest Intraoperative % Change in MAP From Baseline	Lowest intraoperative percent (%) change in mean arterial pressure (MAP) from baseline (average in each group)	30 minutes
Secondary	Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation	Incidence of apneic episodes intraoperatively requiring positive pressure ventilation in each group	30 minutes