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Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

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ClinicalTrials.gov Identifier: NCT03251170
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

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

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Ketamine Drug: Fentanyl Drug: Midazolam Phase 4

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-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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine-based Versus Opioid-based for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : May 10, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Shock

Arm Intervention/treatment
Experimental: Ketamine group
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.
Drug: Ketamine
Patients will receive :1 mg/Kg ketamine for induction of anesthesia
Other Name: Katalar

Drug: Midazolam
Patients will receive 0.05 mg/Kg midazolam
Other Name: Dormicum

Active Comparator: Fentanyl
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.
Drug: Fentanyl
Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia

Drug: Midazolam
Patients will receive 0.05 mg/Kg midazolam
Other Name: Dormicum




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251170


Contacts
Contact: Ahmed Hasanin, Professor +201095076954 ahmedmohamedhasanin@gmail.com

Locations
Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: ahmed Hasanin, Lecturer    +2010095076954    ahmedmohamedhasanin@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Ahmed Mukhtar Head of research committee section in anesthesia department

Responsible Party: Ahmed Hasanin, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03251170     History of Changes
Other Study ID Numbers: N-12-2018
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anesthetics
Ketamine
Fentanyl
Midazolam
Succinylcholine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents