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

Phase 3
Completed
Conditions
Septic Shock
Interventions
Registration Number
NCT03104140
Lead Sponsor
Cairo University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ketamine groupKetamineThis 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.
Thiopental groupThiopental2 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.
Primary Outcome Measures
NameTimeMethod
Mean arterial pressure30 minutes after induction of anesthesia

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

Secondary Outcome Measures
NameTimeMethod
heart rate30 minutes after induction of anesthesia

heart rate measured in beat per minute

cardiac output30 minutes after induction of anesthesia

cardiac output measured in litres per minute measured by electrical velocimetry

stroke volume30 minutes after induction of anesthesia

cardiac stroke volume in milliliters measured by electrical velocimetry

Serum lactate30 minutes after induction of anesthesia

serum lactate measured in mmol/liter

total norepinephrine dose30 minutes after induction of anesthesia

total dose of norepinephrine measured in micrograms

intra-operative inhalational anesthetic concentration30 minutes

the concentration of inhalational anesthetic (%)

incidence of post-induction hypotension5 minutes

The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

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