We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260662
First Posted: December 15, 2010
Last Update Posted: July 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
  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
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

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 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

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


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

  • 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.


Enrollment: 271
Study Start Date: November 2010
Study Completion Date: August 2013
Primary Completion Date: August 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
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
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
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01260662     History of Changes
Other Study ID Numbers: HSR 10-3230
First Submitted: December 13, 2010
First Posted: December 15, 2010
Results First Submitted: April 10, 2015
Results First Posted: April 29, 2015
Last Update Posted: July 14, 2015
Last Verified: June 2015

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:
Propofol
Ketamine
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