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

• 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: Hennepin Healthcare Research Institute
• Information provided by (Responsible Party): Hennepin Healthcare Research Institute

Tracking Information

• First Submitted Date: December 13, 2010
• First Posted Date: December 15, 2010
• Results First Submitted Date: April 10, 2015
• Results First Posted Date: April 29, 2015
• Last Update Posted Date: July 14, 2015
• Study Start Date: November 2010
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
• 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

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Procedural Sedation

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 15, 2015): 271
• Original Estimated Enrollment (submitted: December 14, 2010): 100
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01260662
• Other Study ID Numbers: HSR 10-3230
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hennepin Healthcare Research Institute
• Study Sponsor: Hennepin Healthcare Research Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: James R Miner, MD; Hennepin Healthcare Research Institute

• PRS Account: Hennepin Healthcare Research Institute
• Verification Date: June 2015