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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

Tracking Information
First Submitted Date  ICMJE December 13, 2010
First Posted Date  ICMJE December 15, 2010
Results First Submitted Date  ICMJE April 10, 2015
Results First Posted Date  ICMJE April 29, 2015
Last Update Posted Date July 14, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2010)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2010)
  • respiratory depression [ Time Frame: from start of sedation procedure to end of sedation procedure, up to 24 hours ]
    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. ]
    measured by 100 mm visual analog scales
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Procedural Sedation
Intervention  ICMJE
  • Drug: Propofol
    1 mg/kg IV bolus followed by 0.5 mg/kg 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Propofol
    Deep sedation using propofol
    Intervention: Drug: Propofol
  • 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
    Intervention: Drug: 1:1 Propofol/Ketamine
  • 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
    Intervention: Drug: 4:1 Propofol/Ketamine
Publications * Miner JR, Moore JC, Austad EJ, Plummer D, Hubbard L, Gray RO. Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. Ann Emerg Med. 2015 May;65(5):479-488.e2. doi: 10.1016/j.annemergmed.2014.08.046. Epub 2014 Oct 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2015)
271
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2010)
100
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01260662
Other Study ID Numbers  ICMJE HSR 10-3230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hennepin Healthcare Research Institute
Study Sponsor  ICMJE Hennepin Healthcare Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James R Miner, MD Hennepin Healthcare Research Institute
PRS Account Hennepin Healthcare Research Institute
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP