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Completed

NCT Number: NCT01260662

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

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

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

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

Primary outcomes

  1. Clinical Interventions During Sedation

    Time frame: 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

  2. Hypoxia

    Time frame: From start of sedation procedure to end of sedation procedure, up to 24 hours

    Pulse oximetry

Secondary outcomes

  1. Respiratory Depression

    Time frame: From start of sedation procedure to end of sedation procedure, up to 24 hours

    Continuous capnographic monitoring

  2. Procedural Recall

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2010
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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