Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

Ketamine

Brief Summary

The aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients

Intervention / Treatment

  • Ketamine (DRUG)
    Patients will receive :1 mg/Kg ketamine for induction of anesthesia
  • Fentanyl (DRUG)
    Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
  • Midazolam (DRUG)
    Patients will receive 0.05 mg/Kg midazolam

Condition or Disease

  • Septic Shock

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 42 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 25, 2018 ACTUAL
    Primary Completion: Dec 25, 2019 ACTUAL
    Completion Date: Dec 30, 2019 ACTUAL
    Study First Posted: Aug 16, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 25, 2020

    Sponsors / Collaborators

    Lead Sponsor: Cairo University
    Responsible Party: N/A

    Location

    Cairo, Egypt

    Induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. Most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. Theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability.

    Ketamine has been reported as an induction anesthetic with a sympathomimetic activity. In patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (ABP). Despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear. No studies to the best of our knowledge compared Ketamine-based and opioid-based protocols in rapid sequence induction of anesthesia in hemodynamically unstable patients.

    In this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or fentanyl for induction of anesthesia. After induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. Invasive blood pressure will be monitored through a transducer connected to arterial catheter. Electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.

    Participant Groups

    • This group of patients will receive: 1 mg/Kg ketamine + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

    • 2.5 mg/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia. Endotracheal tube will be inserted aided by 1 mg/Kg succinyl choline. Patients will undergo surgical procedure to eliminate the source of sepsis e.g. abdominal exploration. Invasive blood pressure monitor will be connected to the patient through an arterial catheter. Electrical velocimetry (cardiometry) device will be connected to the patient to measure cardiac output, stroke volume, and systemic vascular resistance.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Sepsis patients
    * With shock index (heart rate divided by systolic blood pressure) \>0.7. or Sepsis patients with norepinephrine infusion.

    Exclusion Criteria:

    * Traumatic brain injury
    * Cerebrovascular disorders

    Primary Outcomes

    • Mean arterial blood pressure measured by invasive transducer attached to arterial catheter

    Secondary Outcomes

    • cardiac output measured in litres per minute measured by electrical velocimetry

    • cardiac stroke volume in milliliters measured by electrical velocimetry

    • heart rate measured in beat per minute

    • serum lactate measured in mmol/liter

    • total dose of norepinephrine measured in micrograms

    • the concentration of inhalational anesthetic (%)

    • The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia or increasing the dose of vasopressors

    More Details

    NCT Number: NCT03251170
    Other IDs: N-12-2018
    Study URL: https://clinicaltrials.gov/study/NCT03251170
    Last updated: Sep 29, 2023