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NCT03139279 · ClinicalTrials.gov registry record · Phase 4
Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy
A Phase 4 study, sponsored by State University of New York - Downstate Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 122
- Enrollment target
NCT03139279 is a Phase 4 study that has completed, run by State University of New York - Downstate Medical Center. The registered enrollment target is 122 participants.
The verdict
NCT03139279, a Phase 4 study, has completed, sponsored by State University of New York - Downstate Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 122 participants
- Enrollment target
Study 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).
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
- OTHER Saline placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2017-05-05 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03139279
The ClinicalTrials.gov registry entry for NCT03139279 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Downstate Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexmedetomidine is the first listed.
NCT03139279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03139279 about?
NCT03139279 is a clinical study titled "Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy". 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...
What is the current status of trial NCT03139279?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 122 participants. The study started on 2017-05-05. Estimated completion is 2018-07-19.
What interventions are being tested in trial NCT03139279?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG), Saline placebo (OTHER).
Who is sponsoring clinical trial NCT03139279?
This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
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