Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Procedural Sedation |
Drug: Propofol Drug: 1:1 Propofol/Ketamine Drug: 4:1 Propofol/Ketamine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Blinded Three Arm Trial of Propofol, 1:1 Combination of Propofol and Ketamine, and 4:1 Combination of Propofol and Ketamine for Procedural Sedation in the Emergency Department |
- Clinical interventions during sedation [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ] [ Designated as safety issue: Yes ]Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
- Hypoxia [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ] [ Designated as safety issue: Yes ]Pulse oximetry
- Respiratory depression [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ] [ Designated as safety issue: Yes ]Continuous capnographic monitoring
- Procedural pain and recall [ Time Frame: Immediately after the end of the procedure, a single time point with 30 minutes of procedures conclusion. ] [ Designated as safety issue: No ]Measured by 100 mm visual analog scales
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Propofol
Deep sedation using propofol
|
Drug: Propofol
1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
|
|
Experimental: 1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation
|
Drug: 1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
|
|
Experimental: 4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation
|
Drug: 4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
|
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department
Exclusion Criteria:
- Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score >2
Contacts and Locations| Contact: Lila Steinberg | research.hcmed@gmail.com |
| United States, Minnesota | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Principal Investigator: James R Miner, MD | |
| Principal Investigator: | James R Miner, MD | Minneapolis Medical Research Foundation |
More Information
No publications provided
| Responsible Party: | Minneapolis Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01260662 History of Changes |
| Other Study ID Numbers: | HSR 10-3230 |
| Study First Received: | December 13, 2010 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Minneapolis Medical Research Foundation:
|
Deep Procedural Sedation Propofol Ketamine Emergency Department |
Monitoring Capnography Procedural Sedation in the Emergency Department |
Additional relevant MeSH terms:
|
Ketamine Propofol Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 19, 2013