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Ketamine Versus Low Dose Thiopental for Induction of Anesthesia in Septic Shock

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ClinicalTrials.gov Identifier: NCT03104140
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date July 10, 2018
Actual Study Start Date  ICMJE April 12, 2017
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2017)
Mean arterial pressure [ Time Frame: 30 minutes after induction of anesthesia ]
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Mean arterial pressure [ Time Frame: one minute after induction of anesthesia ]
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • cardiac output [ Time Frame: 30 minutes after induction of anesthesia ]
    cardiac output measured in litres per minute measured by electrical velocimetry
  • stroke volume [ Time Frame: 30 minutes after induction of anesthesia ]
    cardiac stroke volume in milliliters measured by electrical velocimetry
  • heart rate [ Time Frame: 30 minutes after induction of anesthesia ]
    heart rate measured in beat per minute
  • Serum lactate [ Time Frame: 30 minutes after induction of anesthesia ]
    serum lactate measured in mmol/liter
  • total norepinephrine dose [ Time Frame: 30 minutes after induction of anesthesia ]
    total dose of norepinephrine measured in micrograms
  • intra-operative inhalational anesthetic concentration [ Time Frame: 30 minutes ]
    the concentration of inhalational anesthetic (%)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • cardiac output [ Time Frame: one minute after induction of anesthesia ]
    cardiac output measured in litres per minute measured by electrical velocimetry
  • stroke volume [ Time Frame: one minute after induction of anesthesia ]
    cardiac stroke volume in milliliters measured by electrical velocimetry
  • heart rate [ Time Frame: one minute after induction of anesthesia ]
    heart rate measured in beat per minute
  • Serum lactate [ Time Frame: 30 minutes after induction of anesthesia ]
    serum lactate measured in mmol/liter
  • total norepinephrine dose [ Time Frame: 30 minutes after induction of anesthesia ]
    total dose of norepinephrine measured in micrograms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Low Dose Thiopental for Induction of Anesthesia in Septic Shock
Official Title  ICMJE Ketamine Versus Low Dose Thiopental for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock
Brief Summary The aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus thiopental-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.
Detailed Description

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 and low dose thiopental 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 thiopental 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE
  • Drug: Ketamine
    After fluid resuscitation, patients will receive :1 mg/Kg ketamine + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia
    Other Name: Katalar
  • Drug: Thiopental
    After fluid resuscitation, patients will receive :2 mg/Kg Thiopental + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia
    Other Name: Intraval
Study Arms  ICMJE
  • Experimental: Ketamine group
    This group of patients will receive: 1 mg/Kg ketamine + 0.5 ug/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.
    Intervention: Drug: Ketamine
  • Active Comparator: Thiopental group
    2 mg/Kg thiopental + 0.5 ug/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.
    Intervention: Drug: Thiopental
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2018)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2017)
22
Actual Study Completion Date  ICMJE April 15, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03104140
Other Study ID Numbers  ICMJE N-22-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Hasanin, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department
PRS Account Cairo University
Verification Date July 2018

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