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

Phase 4

Completed

• Conditions: Procedural Sedation
• Interventions: Drug: Propofol

• Registration Number: NCT01260662
• Lead Sponsor: Hennepin Healthcare Research Institute

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 available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2015-04-10
• Results First Submitted QC: 2015-04-10
• Results First Posted: 2015-04-29
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Deep sedation using propofol

Primary Outcome Measures

Name	Time	Method
Clinical Interventions During Sedation	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	From start of sedation procedure to end of sedation procedure, up to 24 hours	Pulse oximetry

Secondary Outcome Measures

Name	Time	Method
Respiratory Depression	From start of sedation procedure to end of sedation procedure, up to 24 hours	Continuous capnographic monitoring
Procedural Recall	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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States