Clinical trial NCT03251170: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean arterial pressure
timeFrame: 30 minutes after induction of anesthesia
Secondary outcomes:
measure: cardiac output
timeFrame: 30 minutes after induction of anesthesia
measure: Stroke volume
timeFrame: 30 minutes after induction of anesthesia
measure: heart rate
timeFrame: 30 minutes after induction of anesthesia
measure: serum lactate
timeFrame: 30 minutes after induction of anesthesia
measure: total norepinephrine dose
timeFrame: 30 minutes after induction of anesthesia
measure: Intra-operative inhalational anesthetic concentration
timeFrame: 30 minutes
measure: Incidence of post-induction hypotension
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar
role: STUDY_DIRECTOR
References: