MedTrace Logo

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

NCT03139279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2019-07-29

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine 0.3 ug/kg intravenous bolus

OTHER

Saline placebo

Intravenous saline/placebo

DRUG

Propofol

Propofol titrated intravenous boluses

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    lead OTHER

Principal Investigators

  • Dennis Dimaculangan, MD · SUNY Downstate Medical Center Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2018-05-04
Completion
2018-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139279 on ClinicalTrials.gov