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NCT01260662 · ClinicalTrials.gov registry record · Phase 4
Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
A Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 271
- Enrollment target
NCT01260662 is a Phase 4 study that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 271 participants.
The verdict
NCT01260662, a Phase 4 study, has completed, sponsored by Hennepin Healthcare Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 271 participants
- Enrollment target
Study Summary
This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.
Interventions
- DRUG Propofol
- DRUG 1:1 Propofol/Ketamine
- DRUG 4:1 Propofol/Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01260662
The ClinicalTrials.gov registry entry for NCT01260662 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hennepin Healthcare Research Institute, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Propofol is the first listed.
NCT01260662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01260662 about?
NCT01260662 is a clinical study titled "Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation". This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for pr...
What is the current status of trial NCT01260662?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 271 participants. The study started on 2010-11. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01260662?
The interventions under investigation include: Propofol (DRUG), 1:1 Propofol/Ketamine (DRUG), 4:1 Propofol/Ketamine (DRUG).
Who is sponsoring clinical trial NCT01260662?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
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