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

NCT ID: NCT03104140

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2018-04-15

Brief 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.

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

Thiopental

Intervention Type: DRUG

After fluid resuscitation, patients will receive :2 mg/Kg Thiopental + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Katalar; Intraval

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Principal investigator, Lecturer of anesthesia and critical care medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Mukhtar, Professor

Role: STUDY_DIRECTOR

Head of research committee section in anesthesia department

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-22-2017

Identifier Type: -

Identifier Source: org_study_id