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Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Fentanyl
Midazolam
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine group

Fentanyl

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cardiac output
cardiac output measured in litres per minute measured by electrical velocimetry
Stroke volume
cardiac stroke volume in milliliters measured by electrical velocimetry
heart rate
heart rate measured in beat per minute
serum lactate
serum lactate measured in mmol/liter
total norepinephrine dose
total dose of norepinephrine measured in micrograms
Intra-operative inhalational anesthetic concentration
the concentration of inhalational anesthetic (%)
Incidence of post-induction hypotension
The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia or increasing the dose of vasopressors

Full Information

First Posted
August 12, 2017
Last Updated
January 25, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03251170
Brief Title
Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock
Official Title
Ketamine-based Versus Opioid-based for Rapid-sequence Induction of Anesthesia in Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
December 25, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Katalar
Intervention Description
Patients will receive :1 mg/Kg ketamine for induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
Patients will receive 0.05 mg/Kg midazolam
Primary Outcome Measure Information:
Title
Mean arterial pressure
Description
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
Time Frame
30 minutes after induction of anesthesia
Secondary Outcome Measure Information:
Title
cardiac output
Description
cardiac output measured in litres per minute measured by electrical velocimetry
Time Frame
30 minutes after induction of anesthesia
Title
Stroke volume
Description
cardiac stroke volume in milliliters measured by electrical velocimetry
Time Frame
30 minutes after induction of anesthesia
Title
heart rate
Description
heart rate measured in beat per minute
Time Frame
30 minutes after induction of anesthesia
Title
serum lactate
Description
serum lactate measured in mmol/liter
Time Frame
30 minutes after induction of anesthesia
Title
total norepinephrine dose
Description
total dose of norepinephrine measured in micrograms
Time Frame
30 minutes after induction of anesthesia
Title
Intra-operative inhalational anesthetic concentration
Description
the concentration of inhalational anesthetic (%)
Time Frame
30 minutes
Title
Incidence of post-induction hypotension
Description
The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia or increasing the dose of vasopressors
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mukhtar
Organizational Affiliation
Head of research committee section in anesthesia department
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock

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