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

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

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.

Study Overview

• Status: Completed
• Conditions: Procedural Sedation
• Intervention / Treatment: Drug: Propofol; Drug: 1:1 Propofol/Ketamine; Drug: 4:1 Propofol/Ketamine

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Interventions During Sedation	Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation	From start of sedation procedure to end of sedation procedure, up to 24 hours
Hypoxia	Pulse oximetry	From start of sedation procedure to end of sedation procedure, up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Depression	Continuous capnographic monitoring	From start of sedation procedure to end of sedation procedure, up to 24 hours
Procedural Recall	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.	Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (ESTIMATE): December 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 14, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Monitoring; Ketamine; Emergency Department; Propofol; Capnography; Deep Procedural Sedation; Procedural Sedation in the Emergency Department
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: HSR 10-3230