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Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269307
First Posted: January 4, 2011
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  Purpose
The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of propofol and ketamine is equivalent in complications, patient and physician satisfaction, post-procedure pain level, and procedural outcome to propofol sedation alone.

Condition Intervention
Sedation Procedure: 1:1 ketamine-propofol mixture sedation Procedure: Propofol Sedation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • airway complications [ Time Frame: within 12 months of study completion ]
    The use of any: Adjunctive airway device (nasopharyngeal airway (NPA)/oropharyngeal airway (OPA), Jaw thrust or other airway maneuver., Use of Bag Valve Mask (BVM) for ventilation and reversal medications (i.e. Narcan).

  • subclinical respiratory depression [ Time Frame: within 12 months of study completion ]
    subclinical respiratory depression (hypoxemia despite supplemental oxygen noted on pulse-oximetry, loss of End-tidal carbon dioxide concentration in the expired air (ETCO2) waveform for 15 seconds or greater, systolic pressure (SBP) below 80mm Hg, cardiac arrhythmias.)

  • satisfaction [ Time Frame: within 12 months of study completion ]
    Following sedation, questionnaires were completed by the sedating physician, any consultant physician, nurse, and patient


Enrollment: 99
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1:1 ketamine - propofol mixture Procedure: 1:1 ketamine-propofol mixture sedation

Prepare Ketamine and Propofol 10mg/cc of ketamine 10mg/cc of propofol mix 1:1 in 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus. Repeat dose 0.025 - 0.05 every 60-90 seconds as needed to reach and maintain target level of sedation.

May round to nearest 0.5-1 cc. Note - 1 cc = 5mg of propofol and 5mg of ketamine

Other Name: Ketofol
Active Comparator: propofol
propofol
Procedure: Propofol Sedation

Prepare Propofol 10mg/cc of propofol 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus over 30 seconds. Repeat dose 0.025 - 0.05 cc/kg every 30-60 seconds as needed to reach and maintain target level of sedation.

May round to nearest 0.5 cc Note - 1 cc = 10 mg of propofol

Other Name: Propofol

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking patients eighteen and older who present to the University of Utah Emergency Department and require, in their treating physician's opinion, procedural sedation for a procedure or radiologic study performed in the Emergency Department.

Exclusion Criteria:

  • Include prior sensitization or allergic reaction to propofol, ketamine, soy or egg products; hemodynamic instability; clinical evidence of head injury, increased intracranial or intraocular pressure; use of drugs known to interact with either study agent, pregnancy with a live intra-uterine pregnancy (i.e. undergoing Dilation and Curettage for intrauterine fetal demise or spontaneous abortion is not an exclusion criteria).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269307


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Scott Youngquist, MD MSc University of Utah
Principal Investigator: Virgil Davis, MD University of Utah
Principal Investigator: Troy Madsen, MD University of Utah
Principal Investigator: Anas Sawas, MS MPH University of Utah
Principal Investigator: Matthew Ahern, DO University of Utah
  More Information

Publications:

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01269307     History of Changes
Other Study ID Numbers: 39736
First Submitted: December 10, 2010
First Posted: January 4, 2011
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by University of Utah:
Anesthesia
Pain
Procedural sedation
Airway/Anesthesia/Analgesia

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action