CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Dexmedetomidine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03139279
NCT03139279Phase 4Completed

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

State University of New York - Downstate Medical Center·interventional·Posted May 3, 2017·Updated Jul 29, 2019

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine, Saline placebo, and 1 other intervention for Colonoscopy. Completed, enrolled 122 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartMay 5, 2017
Primary CompletionMay 4, 2018
Study CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.2 years ago

Interventions

Dexmedetomidinedrug

Dexmedetomidine 0.3 ug/kg intravenous bolus

Saline placeboother

Intravenous saline/placebo

Propofoldrug

Propofol titrated intravenous boluses