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

Procedural Sedation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Procedural Sedation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Propofol1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

Drug:1:1 Propofol/KetaminePropofol 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

Drug:4:1 Propofol/KetaminePropofol 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropofolDeep sedation using propofol

1:1 Propofol/KetaminePropofol 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

4:1 Propofol/KetaminePropofol 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

Study Status

Completed

Start Date: November 2010

Completed Date: August 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Clinical Interventions During Sedation

Secondary Outcome: Respiratory Depression

Study sponsors, principal investigator, and references

Principal Investigator: James R Miner, MD

Lead Sponsor: Minneapolis Medical Research Foundation

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01260662

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