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

Phase 3

Completed

• Conditions: Septic Shock
• Interventions: Drug: ketamine full dose; Drug: ketamine half dose; Drug: Midazolam; Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT03844984
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2019-02-20
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-23
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Adult patients aged above 18 years
• With septic shock
• Scheduled for general anesthesia

Exclusion Criteria

• Patients under 18 years
• Burn patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine-ketamine group	ketamine half dose	This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Ketamine group	Midazolam	This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Lidocaine-ketamine group	Midazolam	This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
Ketamine group	ketamine full dose	This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Ketamine group	Normal saline	This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
Lidocaine-ketamine group	Lidocaine	This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	10 minutes after induction of general anesthesia	Mean arterial blood pressure measured in mmHg

Secondary Outcome Measures

Name	Time	Method
Cardiac output	10 minutes after induction of general anesthesia	Volume of blood pumped by the heart in one minute measured in liters per minute
Heart rate	10 minutes after induction of general anesthesia	Number of heart beats per minute
The number of patients who suffer from post-induction hypotension.	5 minutes after induction of general anesthesia	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
Norepinephrine consumption	10 minutes after induction of general anesthesia	The total dose of norepinephrine measured in micrograms
Systolic blood pressure	10 minutes after induction of general anesthesia	Systolic arterial blood pressure measured in mmHg

Trial Locations

Locations (1)

Ahmed Mohamed Hasanin; 🇪🇬 Cairo, Egypt