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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03104140
Enrollment
26
Registered
2017-04-07
Start date
2017-04-12
Completion date
2018-04-15
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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.

Interventions

DRUGKetamine

After fluid resuscitation, patients will receive :1 mg/Kg ketamine + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial pressure30 minutes after induction of anesthesiaMean arterial blood pressure measured by invasive transducer attached to arterial catheter

Secondary

MeasureTime frameDescription
stroke volume30 minutes after induction of anesthesiacardiac stroke volume in milliliters measured by electrical velocimetry
heart rate30 minutes after induction of anesthesiaheart rate measured in beat per minute
Serum lactate30 minutes after induction of anesthesiaserum lactate measured in mmol/liter
cardiac output30 minutes after induction of anesthesiacardiac output measured in litres per minute measured by electrical velocimetry
intra-operative inhalational anesthetic concentration30 minutesthe concentration of inhalational anesthetic (%)
incidence of post-induction hypotension5 minutesThe percent of patients with severe hypotension after induction of anesthesia requiring stoppage of inhalational anesthesia
total norepinephrine dose30 minutes after induction of anesthesiatotal dose of norepinephrine measured in micrograms

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026