Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
NCT01260662 is a Phase 4 study that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 271 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
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 |
What the finished NCT01260662 record still lists
NCT01260662 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Propofol is the first listed.
NCT01260662 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01260662's enrollment target sits among peer trials
271 316th of 2000 higher than 1,683 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03609216 · 271 participants · Phase 2
Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
- NCT02468024 · 272 participants · Phase 3
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
- NCT05519449 · 272 participants · Phase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
- NCT06035939 · 272 participants · NA
SMYLS Multi-site Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia