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NCT01126957
Combined Ketamine/Propofol for Emergency Department Procedural Sedation
NA trial testing Ketamine in Procedural Sedation and Analgesia in 107 participants. Terminated before completion.
1 March 2010
Quick facts
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 1 May 2007 |
| Primary completion | 1 March 2010 |
| Estimated completion | 1 March 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ketamine (ketamine) — full drug profile →
- Placebo
- Fentanyl (fentanyl) — full drug profile →
- Propofol (Propofol) — full drug profile →
Conditions studied
- Procedural Sedation and Analgesia — all drugs for Procedural Sedation and Analgesia →
Sponsor
University of Missouri-Columbia
Who can join
1 and older, any sex, with Procedural Sedation and Analgesia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Respiratory Depression
Time frame: Baseline and throughout procedure
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01126957
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Other recruiting trials for Procedural Sedation and Analgesia
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01126957 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
- Last refreshed: 29 March 2023
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