Ketamine Versus Fentanyl for Induction of Anesthesia in Septic Shock
NCT ID: NCT03251170
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2018-01-25
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Ketamine
Patients will receive :1 mg/Kg ketamine for induction of anesthesia
Midazolam
Patients will receive 0.05 mg/Kg midazolam
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.
Fentanyl
Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
Midazolam
Patients will receive 0.05 mg/Kg midazolam
Interventions
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Ketamine
Patients will receive :1 mg/Kg ketamine for induction of anesthesia
Fentanyl
Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
Midazolam
Patients will receive 0.05 mg/Kg midazolam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With shock index (heart rate divided by systolic blood pressure) \>0.7. or Sepsis patients with norepinephrine infusion.
Exclusion Criteria
* Cerebrovascular disorders
18 Years
65 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Hasanin
Assistant professor
Principal Investigators
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Ahmed Mukhtar
Role: STUDY_DIRECTOR
Head of research committee section in anesthesia department
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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N-12-2018
Identifier Type: -
Identifier Source: org_study_id
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