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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104140
• Other study ID #: N-22-2017
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 15, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	Mean arterial blood pressure measured by invasive transducer attached to arterial catheter	30 minutes after induction of anesthesia
Secondary	cardiac output	cardiac output measured in litres per minute measured by electrical velocimetry	30 minutes after induction of anesthesia
Secondary	stroke volume	cardiac stroke volume in milliliters measured by electrical velocimetry	30 minutes after induction of anesthesia
Secondary	heart rate	heart rate measured in beat per minute	30 minutes after induction of anesthesia
Secondary	Serum lactate	serum lactate measured in mmol/liter	30 minutes after induction of anesthesia
Secondary	total norepinephrine dose	total dose of norepinephrine measured in micrograms	30 minutes after induction of anesthesia
Secondary	intra-operative inhalational anesthetic concentration	the concentration of inhalational anesthetic (%)	30 minutes
Secondary	incidence of post-induction hypotension	The percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia	5 minutes