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

NCT01269307 | Completed DMC

• 1 other identifier: 39736
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedation

Keywords

Anesthesia; Pain; Procedural sedation; Airway/Anesthesia/Analgesia

Outcome Measures

Primary Outcomes (3)

• airway complications

  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).

  within 12 months of study completion

• subclinical respiratory depression

  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.)

  within 12 months of study completion

• satisfaction

  Following sedation, questionnaires were completed by the sedating physician, any consultant physician, nurse, and patient

  within 12 months of study completion

Study Arms (2)

1:1 ketamine - propofol mixture

ACTIVE COMPARATOR

Procedure: 1:1 ketamine-propofol mixture sedation

propofol

ACTIVE COMPARATOR

propofol

Procedure: Propofol Sedation

Interventions

1:1 ketamine-propofol mixture sedation PROCEDURE

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

Also known as: Ketofol

1:1 ketamine - propofol mixture

Propofol Sedation PROCEDURE

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

Also known as: Propofol

propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

• Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med. 2007 Jan;49(1):15-22. doi: 10.1016/j.annemergmed.2006.06.042. Epub 2006 Sep 25.

  PMID: 16997421 BACKGROUND

• Miner JR, Gray RO, Stephens D, Biros MH. Randomized clinical trial of propofol with and without alfentanil for deep procedural sedation in the emergency department. Acad Emerg Med. 2009 Sep;16(9):825-34. doi: 10.1111/j.1553-2712.2009.00487.x.

  PMID: 19845550 BACKGROUND

• Burton JH, Miner JR, Shipley ER, Strout TD, Becker C, Thode HC Jr. Propofol for emergency department procedural sedation and analgesia: a tale of three centers. Acad Emerg Med. 2006 Jan;13(1):24-30. doi: 10.1197/j.aem.2005.08.011. Epub 2005 Dec 19.

  PMID: 16365337 BACKGROUND

• Zed PJ, Abu-Laban RB, Chan WW, Harrison DW. Efficacy, safety and patient satisfaction of propofol for procedural sedation and analgesia in the emergency department: a prospective study. CJEM. 2007 Nov;9(6):421-7. doi: 10.1017/s148180350001544x.

  PMID: 18072987 BACKGROUND

• Friedberg BL. Propofol-ketamine technique: dissociative anesthesia for office surgery (a 5-year review of 1264 cases). Aesthetic Plast Surg. 1999 Jan-Feb;23(1):70-5. doi: 10.1007/s002669900245.

  PMID: 10022941 BACKGROUND

• Friedberg BL. Propofol ketamine anesthesia for cosmetic surgery in the office suite. Int Anesthesiol Clin. 2003 Spring;41(2):39-50. doi: 10.1097/00004311-200341020-00006. No abstract available.

  PMID: 12711912 BACKGROUND

• Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.

  PMID: 18754820 BACKGROUND

• Slavik VC, Zed PJ. Combination ketamine and propofol for procedural sedation and analgesia. Pharmacotherapy. 2007 Nov;27(11):1588-98. doi: 10.1592/phco.27.11.1588.

  PMID: 17963466 BACKGROUND

• Bowdle TA, Radant AD, Cowley DS, Kharasch ED, Strassman RJ, Roy-Byrne PP. Psychedelic effects of ketamine in healthy volunteers: relationship to steady-state plasma concentrations. Anesthesiology. 1998 Jan;88(1):82-8. doi: 10.1097/00000542-199801000-00015.

  PMID: 9447860 BACKGROUND

• Willman EV, Andolfatto G. A prospective evaluation of "ketofol" (ketamine/propofol combination) for procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2007 Jan;49(1):23-30. doi: 10.1016/j.annemergmed.2006.08.002. Epub 2006 Oct 23.

  PMID: 17059854 BACKGROUND

• Sharieff GQ, Trocinski DR, Kanegaye JT, Fisher B, Harley JR. Ketamine-propofol combination sedation for fracture reduction in the pediatric emergency department. Pediatr Emerg Care. 2007 Dec;23(12):881-4. doi: 10.1097/pec.0b013e31815c9df6.

  PMID: 18091596 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: January 4, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)