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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Virgil Davis, University of Utah
ClinicalTrials.gov Identifier:
NCT01269307
First received: December 10, 2010
Last updated: August 15, 2012
Last verified: August 2012
  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 Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Following sedation, questionnaires were completed by the sedating physician, any consultant physician, nurse, and patient


Estimated Enrollment: 130
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269307

Contacts
Contact: Virgil Davis, MD 8015812417 Virgil.Davis@hsc.utah.edu
Contact: Anas Sawas, MS, MPH (801) 839-4742 ansawas@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Virgil Davis, MD    801-581-2417    virgil.davis@hsc.utah.edu   
Principal Investigator: Virgil Davis, MD         
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
Principal Investigator: Camille Broadwater-Hollifield, M.P.H. University of Utah, Division of Emergency Medicine
  More Information

Publications:

Responsible Party: Virgil Davis, principal investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01269307     History of Changes
Other Study ID Numbers: 39736
Study First Received: December 10, 2010
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014