Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Procedural Sedation
Intervention: Propofol (Drug); 1:1 Propofol/Ketamine (Drug); 4:1 Propofol/Ketamine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Minneapolis Medical Research Foundation Official(s) and/or principal investigator(s): James R Miner, MD, Principal Investigator, Affiliation: Minneapolis Medical Research Foundation
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Interventions During SedationHypoxia
Secondary outcome: Respiratory DepressionProcedural Recall
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
Additional Information
Starting date: November 2010
Last updated: June 15, 2015
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