Combined Ketamine/Propofol for Emergency Department Procedural Sedation

NCT01126957 | Terminated Results

• 1 other identifier: Project Number: 1084480
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. Obviously the optimal agent or combination of agents has not been identified. There are reasons to believe that a combination of ketamine and propofol may have advantages over other agents/combinations. These include better hemodynamic stability at equal depth of anesthesia with a combination of ketamine/propofol than with propofol alone, less respiratory depression with the combination in comparison to propofol alone, and preservation of respiratory drive with the combination. There is one study of ketamine/propofol in Emergency Department (ED) procedural sedation which demonstrated the safety and effectiveness of the combination, but did not compare it to any other agents or combinations. The investigators designed a randomized, placebo controlled study to compare propofol to propofol and ketamine for adequacy of sedation and respiratory depression in Emergency Department procedural sedation and analgesia. The investigators hypothesis was that the combination of propofol/ketamine would produce better sedation and/or less respiratory depression than propofol alone. Methods Study design The investigators conducted a randomized, prospective, double-blinded study of all patients receiving procedural sedation. From April 2007 until July 2009 in the ED of a 274 bed university teaching hospital. The study was approved by the University of Missouri's Institutional Review Board and informed consent was obtained from all participants.

Conditions

Procedural Sedation and Analgesia

Outcome Measures

Primary Outcomes (1)

• Respiratory Depression

  1. Endotracheal carbon dioxide (ETCO2) rise \> 5mm/hg 2. Arterial oxygen saturation (SaO2) \<90% 3. Respiratory rate (RR) \< 8 br/min 4. Apnea \> 15 sec 5. airway manipulation

  Baseline and throughout procedure

Secondary Outcomes (1)

• Satisfaction With Procedural Sedation

  20 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation.

Drug: Ketamine; Drug: Fentanyl; Drug: Propofol

Placebo

PLACEBO COMPARATOR

Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.

Drug: Placebo; Drug: Fentanyl; Drug: Propofol

Interventions

Ketamine DRUG

Ketamine was given as a 0.5mg / Kg bolus.

Also known as: Ketalar

Ketamine

Placebo DRUG

Placebo given as an bolus to control group.

Placebo

Fentanyl DRUG

Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo

Also known as: Sublimaze

Ketamine; Placebo

Propofol DRUG

Propofol given to both arms to maintain sedation throughout procedure.

Also known as: Diprivan

Ketamine; Placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \< 1yr
• History of prior adverse reaction to anesthesia
• History of cardiac disease
• History of pulmonary disease
• Hepatic dysfunction
• Thyroid disease
• Pregnancy
• Porphyria
• Psychiatric Illness
• Allergy to eggs, soybeans, or sulfites
• Increased intracranial or intraocular pressure
• Active upper respiratory infection in children
• Abnormal airway
• ASA score of III or greater

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri - Columbia dept. of Emergency Medicine

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Limitations and Caveats

107 participants were consented for the study. 4 were terminated by the investigator as they received surgery and were no longer eligible. No data were analyzed/available as the target number of 200 was not reached; the PI has left the institution.

Results Point of Contact

• Title: Dr. David Henry
• Organization: University of Missouri-Columbia

henryda@missouri.edu

573/884-2582

Study Officials

• Henry David, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 24, 2023
• Results First Posted: May 30, 2017

Record last verified: 2023-03

Locations

US (1)