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

Ketamine Versus Low Dose Thiopental for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Ketamine; Drug: Thiopental

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: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Katalar
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.	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 Names: Intraval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Mean arterial blood pressure measured by invasive transducer attached to arterial catheter	30 minutes after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output	cardiac output measured in litres per minute measured by electrical velocimetry	30 minutes after induction of anesthesia
heart rate	heart rate measured in beat per minute	30 minutes after induction of anesthesia
total norepinephrine dose	total dose of norepinephrine measured in micrograms	30 minutes after induction of anesthesia
stroke volume	cardiac stroke volume in milliliters measured by electrical velocimetry	30 minutes after induction of anesthesia
Serum lactate	serum lactate measured in mmol/liter	30 minutes after induction of anesthesia
intra-operative inhalational anesthetic concentration	the concentration of inhalational anesthetic (%)	30 minutes
incidence of post-induction hypotension	The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia	5 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2017
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 15, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Ketamine; Thiopental
• Other Study ID Numbers: N-22-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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