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Compare the Effect of Propofol vs. "Ketofol" on Hemodynamic Stability During Induction of General Anesthesia

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ClinicalTrials.gov Identifier: NCT02282891
Recruitment Status : Withdrawn (No subjects were ever recruited and enrolled.)
First Posted : November 5, 2014
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 31, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
Number of time points during which blood pressure was below 20% of baseline BP [ Time Frame: up to 30 minutes after intubation ]
The number of time points during which the blood pressure was below 20% of the baseline BP. The first blood pressure upon arrival to the operating room before any anesthetic medications are administered will be the reference (baseline) blood pressure. BP will be measured every 1 minute from one minute before induction until 30 minutes after endotracheal intubation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
  • Severity of hypotension [ Time Frame: up to 30 minutes after intubation ]
    As determined by the gradient of each blood pressure measurement from the baseline BP
  • Total dosage of vasopressors administered [ Time Frame: up to 30 minutes after intubation ]
    The total dosage of vasopressors administered during induction and up to 30 minutes after endotracheal intubation
  • Amount of IV fluids administered [ Time Frame: up to 30 minutes after intubation ]
    The total amount of IV fluids administered during induction and up to 30 minutes after endotracheal intubation.
  • Additional Medication Usage [ Time Frame: up to 30 minutes after intubation ]
    The total amount of additional medications used during induction and up to 30 minutes after endotracheal intubation.
  • Total Opioid Dosage Used [ Time Frame: up to 30 minutes after intubation ]
    Total intraoperative as well as postoperative opioid dosage used.
  • Post Operative Nausea and Vomiting (PONV) Severity [ Time Frame: 72 hours post surgery ]
    Presence or absence of PONV and severity within 72 hours of surgery
  • Treatment of Post Operative Nausea and Vomiting (PONV) [ Time Frame: 72 hours post surgery ]
    Number and dose of anti-emetics given within 72 hours of surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Effect of Propofol vs. "Ketofol" on Hemodynamic Stability During Induction of General Anesthesia
Official Title  ICMJE A Randomized-Controlled Trial to Compare the Effect of Propofol vs. "Ketofol" on Hemodynamic Stability During Induction of General Anesthesia
Brief Summary The purpose of this study is to compare the hemodynamic effects of a standardized induction of general anesthesia with either propofol or ketofol in patients with physical status classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT) with two arms of treatment groups. One arm will consist of induction of general anesthesia using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose will be 1.5mg/kg of propofol and 0.75mg/kg of ketamine; the second arm will consist of induction of general anesthesia using propofol 2mg/kg. The primary outcome of the intervention will consist of hemodynamic changes during the first 30 minutes after induction of general anesthesia.
Detailed Description

The anesthetic agent propofol can result in hypotension when used for induction of general anesthesia. Recent trials suggest that even a short duration of hypotension during induction of anesthesia can adversely affect organ function and overall outcome.1 To overcome the hypotensive effect of propofol, ketamine, which has sympathomimetic effects, has been combined with propofol to produce a mixture labeled "ketofol", which has been used both for procedural sedation and induction of general anesthesia. Clinical trials have shown that ketofol can attenuate the hypotensive effects of propofol during procedural sedation or induction of general anesthesia in patients whose physical status is 1 or 2 according to the American Society of Anesthesiologists (ASA 1-2), i.e., healthy patients or those with mild-moderate systemic illness.2,3 Clinically, it is important to demonstrate the efficacy of ketofol in attenuating hypotensive effects of propofol in sicker patients, i.e., patients with physical status ASA 3. The purpose of this study is to compare the hemodynamic effects of a standardized induction of general anesthesia with either propofol or ketofol in patients with physical status classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT) with two arms of treatment groups. One arm will consist of induction of general anesthesia using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose will be 1.5mg/kg of propfol and 0.75mg/kg of ketamine; the second arm will consist of induction of general anesthesia using propofol 2mg/kg. The primary outcome of the intervention will consist of hemodynamic changes during the first 30 minutes after induction of general anesthesia.

Baseline demographics collected for each patient will include:

  1. age
  2. sex
  3. ASA physical status
  4. Hx of HTN
  5. Hx of PONV
  6. Preoperative pain score

The standardized induction of anesthesia will consist of intravenous administration of midazolam 0.04mg/kg, lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, glycopyrrolate 0.004 mg/kg, an unlabeled pre-prepared, covered syringe which will be prepared by the Yale Anesthesia satellite pharmacist containing either propofol 2mg/kg or a mixture propofol 1.5mg/kg and ketamine 0.75mg/kg, the amount of which will be pre-determined based on the patient weight, and rocuronium 0.6 mg/kg. A backup 10cc syringe of the study drug will be available as well if the initial dose is inadequate. The choice of propofol and ketamine dosing is based on a study cited earlier by Smischney et al in 2012 that addresses ASA 1-2 patients undergoing induction of general anesthesia. Endotracheal intubation will take place after adequate muscle relaxation has been determined using fade of train of four on a nerve stimulator placed over the ulnar nerve. Additional medication to facilitate induction will be used according to the judgment of the anesthesia provider with a backup syringe of the same study drug. Inhalational anesthesia will be administered after confirmation of endotracheal intubation. Treatment of hypotension will be according to the anesthesia provider. Amounts of intravenous fluids as well as doses of vasopressor that are used during induction and in the subsequent 30 minutes after endotracheal intubation will be obtained from the anesthesia record.

The first blood pressure (BP) upon arrival to the operating room before any anesthetic medications are administered will be the reference (baseline) blood pressure. BP will be measured every 1 minute from one minute before induction until 30 minutes after endotracheal intubation.

The primary outcome of the study will be the number of time points during which the blood pressure was below 20% of the baseline BP. Secondary outcomes will include:

  1. Severity of hypotension as determined by the gradient of each blood pressure measurement from the baseline BP.
  2. The total dosage of vasopressors administered during induction and up to 30 minutes after endotracheal intubation
  3. The total amount of IV fluids administered during induction and up to 30 minutes after endotracheal intubation.
  4. The total amount of additional medications used during induction and up to 30 minutes after endotracheal intubation.
  5. Total intraoperative as well as postoperative opioid dosage used.
  6. Presence or absence of PONV and severity
  7. Intraoperative prophylaxis and postoperative treatment of PONV
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Patients With "ASA 3" Designation
Intervention  ICMJE
  • Drug: Propofol
    Induction of general anesthesia using propofol 2mg/kg
    Other Name: Diprivan
  • Drug: Propofol-Ketamine
    Induction of general anesthesia using a mixture of 1.5 mg/kg:0.75 mg/kg propofol/ketamine
    Other Name: ketofol
Study Arms  ICMJE
  • Active Comparator: Propofol
    Induction of general Anesthesia using propofol 2mg/kg
    Intervention: Drug: Propofol
  • Experimental: Propofol/Ketamine (ketofol)
    Induction of general anesthesia using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine
    Intervention: Drug: Propofol-Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 14, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2014)
90
Actual Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients age 18-80 scheduled for elective surgery
  • Physical status ASA 3.

Exclusion Criteria:

  • Patients with a physical status of ASA 1,2, 4 or 5,
  • Prior adverse reaction to propofol, ketamine or both
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282891
Other Study ID Numbers  ICMJE 1406014189
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamel P Ortoleva, MD Yale University
Principal Investigator: Jean Charchaflieh, MD,MPH,DrPH Yale University
PRS Account Yale University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP