Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

Septic Shock Clinical Trial

Official title:

Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844984
• Other study ID #: N128-2018
• Status: Completed
• Phase: Phase 3
• Start date: February 20, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: November 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.

Description:

Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.

Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.

Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged above 18 years

• With septic shock

• Scheduled for general anesthesia

Exclusion Criteria:

• Patients under 18 years

• Burn patients

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• ketamine full dose
This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
• Midazolam
This group will receive midazolam 0.05 mg/Kg
• Normal saline
This group will receive normal saline 10 mL
• ketamine half dose
This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
• Lidocaine
This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Hasanin	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 blood pressure	Mean arterial blood pressure measured in mmHg	10 minutes after induction of general anesthesia
Secondary	Heart rate	Number of heart beats per minute	10 minutes after induction of general anesthesia
Secondary	The number of patients who suffer from post-induction hypotension.	The number of patients who suffer from decreased mean arterial pressure by 10% from the baseline reading during the first 5 minutes after induction of anesthesia	5 minutes after induction of general anesthesia
Secondary	Cardiac output	Volume of blood pumped by the heart in one minute measured in liters per minute	10 minutes after induction of general anesthesia
Secondary	Norepinephrine consumption	The total dose of norepinephrine measured in micrograms	10 minutes after induction of general anesthesia
Secondary	Systolic blood pressure	Systolic arterial blood pressure measured in mmHg	10 minutes after induction of general anesthesia