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

NCT01260662 | Completed Phase 4 Results

• 1 other identifier: HSR 10-3230
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation

Keywords

Deep Procedural Sedation; Propofol; Ketamine; Emergency Department; Monitoring; Capnography; Procedural Sedation in the Emergency Department

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Respiratory Depression

  From start of sedation procedure to end of sedation procedure, up to 24 hours

• Procedural Recall

  Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.

Study Arms (3)

Propofol

ACTIVE COMPARATOR

Deep sedation using propofol

Drug: Propofol

1:1 Propofol/Ketamine

EXPERIMENTAL

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

4:1 Propofol/Ketamine

EXPERIMENTAL

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

Interventions

Propofol DRUG

1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

Propofol

1:1 Propofol/Ketamine DRUG

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

1:1 Propofol/Ketamine

4:1 Propofol/Ketamine DRUG

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

4:1 Propofol/Ketamine

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department

You may not qualify if:

• Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score \>2

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• 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.

  PMID: 25441247 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

Propofol; Ketamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Results Point of Contact

• Title: James Miner
• Organization: MinneapolisMRF

miner015@umn.edu

612-873-3000

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 14, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-06

Locations

US (1)