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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Minneapolis Medical Research Foundation
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01260662
First received: December 13, 2010
Last updated: October 24, 2013
Last verified: October 2013
  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

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 ] [ 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


Secondary Outcome Measures:
  • 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: August 2014 (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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260662

Contacts
Contact: Lila Steinberg research.hcmed@gmail.com

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Principal Investigator: James R Miner, MD         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
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: October 24, 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
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014