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Completed

NCT Number: NCT03251170

Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Patients will receive :1 mg/Kg ketamine for induction of anesthesia

Other names: Katalar

Fentanyl

Drug

Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia

midazolam

Drug

Patients will receive 0.05 mg/Kg midazolam

Other names: Dormicum

Primary outcomes

  1. Mean arterial pressure

    Time frame: 30 minutes after induction of anesthesia

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

Secondary outcomes

  1. cardiac output

    Time frame: 30 minutes after induction of anesthesia

    cardiac output measured in litres per minute measured by electrical velocimetry

  2. Stroke volume

    Time frame: 30 minutes after induction of anesthesia

    cardiac stroke volume in milliliters measured by electrical velocimetry

  3. heart rate

    Time frame: 30 minutes after induction of anesthesia

    heart rate measured in beat per minute

  4. serum lactate

    Time frame: 30 minutes after induction of anesthesia

    serum lactate measured in mmol/liter

  5. total norepinephrine dose

    Time frame: 30 minutes after induction of anesthesia

    total dose of norepinephrine measured in micrograms

  6. Intra-operative inhalational anesthetic concentration

    Time frame: 30 minutes

    the concentration of inhalational anesthetic (%)

  7. Incidence of post-induction hypotension

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Ketamine-based Versus Opioid-based for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2017
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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