A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters

NCT01065350 | Completed Results DMC

• 1 other identifier: 22063
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Some of these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug combination known as ketofol (ketamine/propofol admixture) during induction and compare them to propofol. If we determine that the changes produced by ketofol are favorable compared with propofol, we then will seek to test its use in the trauma setting in a subsequent randomized controlled trial.

Conditions

Blood Pressure

Keywords

ketofol; hemodynamics; propofol; anesthesia

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia

  Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor \[NICOM\], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.

  Baseline, 5 minutes, 10 minutes, 30 minutes post induction

Secondary Outcomes (13)

• Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia

  Baseline, 5 minutes, 10 minutes, 30 minutes post induction

• Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia

  Baseline, 5 minutes, 10 minutes, 30 minutes post induction

• Average Change in Cardiac Output (CO)

  Baseline, 5 minutes, 10 minutes post induction

• Average Change in Cardiac Index (CI)

  Baseline, 5 minutes, 10 minutes post induction

• Average Change in Heart Rate (HR)

  Baseline, 5 minutes, 10 minutes post induction

Study Arms (2)

Propofol

ACTIVE COMPARATOR

As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.

Drug: Propofol

Ketofol

EXPERIMENTAL

As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.

Drug: Ketamine

Interventions

Propofol DRUG

As part of the induction, subjects will be given 2 milligrams per kilogram of body weight (mg/kg) of propofol. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. The clinician and observer will be blinded to the medication and doses being administered during induction given that both syringes, syringes in the propofol and ketofol groups, will look identical (will both appear to be propofol only). The propofol group will also be given an additional 10 mL syringe of propofol due to any patient responding to stimulus after induction. The 10 mL syringe represents 1 mg/kg of propofol. If patient receives both the 20 and 10ml syringe, he or she will receive a total of 3mg/kg of propofol.

Also known as: Diprivan

Propofol

Ketamine DRUG

As part of the induction, patients will be given 20ml syringe of ketofol which is weight based such that ketamine will represent 0.75mg/kg of the dose and propofol, 1.5mg/kg. The clinician and observer will be blinded to the medication and doses being administered during induction given that both 20ml syringes (propofol group and ketofol group) will look identical (will both appear to be propofol only). Additional 10ml syringe will be given due to any patient responding to stimulus after induction. The 10ml syringe will represent 0.25mg/kg of ketamine and 0.5mg/kg of propofol. If the patient receives both the 20 and 10ml rescue syringe, he or she will receive a total of 1mg/kg of ketamine and 2mg/kg of propofol.

Also known as: Ketalar

Ketofol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.

You may not qualify if:

• patients with age less than 18 yr or over 60 yr,
• emergency surgery,
• patients undergoing neurosurgical procedures,
• any procedure with adjunctive analgesia,
• any patient on chronic opiate use,
• females who are known to be pregnant,
• patients who had ingested psychotropic or sedative medication within one month of investigation,
• patients with personality disorders,
• weight greater than 20% of ideal, and
• any known contraindications to ketamine or propofol.

Sponsors & Collaborators

• Mayo Clinic: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Smischney NJ, Beach ML, Loftus RW, Dodds TM, Koff MD. Ketamine/propofol admixture (ketofol) is associated with improved hemodynamics as an induction agent: a randomized, controlled trial. J Trauma Acute Care Surg. 2012 Jul;73(1):94-101. doi: 10.1097/TA.0b013e318250cdb8.

  PMID: 22743378 RESULT

MeSH Terms

Interventions

Propofol; Ketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Limitations and Caveats

The dose ratio implemented was not ideal. Enrollment was limited to ASA I and II patients only.

Results Point of Contact

• Title: Nathan J. Smischney, MD
• Organization: Mayo Clinic

smischney.nathan@mayo.edu

507-255-6032

Study Officials

• Nathan J Smischney, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Matthew Koff, MD

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 7, 2010
• First Posted: February 9, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-03

Locations

US (1)