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NCT01126957 · ClinicalTrials.gov registry record · NA
Combined Ketamine/Propofol for Emergency Department Procedural Sedation
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 107
- Enrollment target
NCT01126957: Clinical Trial NA study, sponsored by University of Missouri-Columbia.
NCT01126957 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 107 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01126957, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
Study Summary
Introduction Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. The investigators designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. The investigators hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone. Methods Study design The investigators conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.
Primary Outcome
1. Endotracheal carbon dioxide (ETCO2) rise \> 5mm/hg 2. Arterial oxygen saturation (SaO2) \<90% 3. Respiratory rate (RR) \< 8 br/min 4. Apnea \> 15 sec 5. airway manipulation
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Propofol
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-03 |
| Phase | NA |
Why NCT01126957 stopped before completion
NCT01126957 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01126957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01126957 about?
NCT01126957 is a clinical study titled "Combined Ketamine/Propofol for Emergency Department Procedural Sedation". Introduction Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and resp...
What is the current status of trial NCT01126957?
This trial is currently terminated. It is a NA study. The enrollment target is 107 participants. The study started on 2007-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT01126957?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Propofol (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT01126957?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01126957's enrollment target sits among peer trials
107 830th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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