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Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

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ClinicalTrials.gov Identifier: NCT01260662
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : April 29, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Procedural Sedation Drug: Propofol Drug: 1:1 Propofol/Ketamine Drug: 4:1 Propofol/Ketamine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Interventions During Sedation [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ]
    Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation

  2. Hypoxia [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ]
    Pulse oximetry


Secondary Outcome Measures :
  1. Respiratory Depression [ Time Frame: From start of sedation procedure to end of sedation procedure, up to 24 hours ]
    Continuous capnographic monitoring

  2. Procedural Recall [ Time Frame: Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion. ]
    After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260662


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
Investigators
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Principal Investigator: James R Miner, MD Hennepin Healthcare Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT01260662    
Other Study ID Numbers: HSR 10-3230
First Posted: December 15, 2010    Key Record Dates
Results First Posted: April 29, 2015
Last Update Posted: July 14, 2015
Last Verified: June 2015
Keywords provided by Hennepin Healthcare Research Institute:
Deep Procedural Sedation
Propofol
Ketamine
Emergency Department
 Monitoring
Capnography
Procedural Sedation in the Emergency Department
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action