A Phase 4 interventional study of Ketamine and Fentanyl in Septic Shock, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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
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.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's enrollment of 42 is below the median of 78 across 547 interventional studies indexed under Shock, Septic.
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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 · Drug: Midazolam
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 · Drug: Midazolam
Mean arterial pressure
Mean arterial blood pressure measured by invasive transducer attached to arterial catheter
Time frame: 30 minutes after induction of anesthesia
cardiac output
cardiac output measured in litres per minute measured by electrical velocimetry
Time frame: 30 minutes after induction of anesthesia
Stroke volume
cardiac stroke volume in milliliters measured by electrical velocimetry
Time frame: 30 minutes after induction of anesthesia
heart rate
heart rate measured in beat per minute
Time frame: 30 minutes after induction of anesthesia
serum lactate
serum lactate measured in mmol/liter
Time frame: 30 minutes after induction of anesthesia
total norepinephrine dose
total dose of norepinephrine measured in micrograms
Time frame: 30 minutes after induction of anesthesia
Intra-operative inhalational anesthetic concentration
the concentration of inhalational anesthetic (%)
Time frame: 30 minutes
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
Time frame: 5 minutes
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine