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

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Midazolam; Drug: Normal saline; Drug: ketamine full dose; Drug: ketamine half dose; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Ahmed Mohamed Hasanin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under 18 years
• Burn patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine group; This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.	Drug: Midazolam; This group will receive midazolam 0.05 mg/Kg; Other Names: dormicum; Drug: Normal saline; This group will receive normal saline 10 mL; Drug: ketamine full dose; This group will receive induction of anesthesia using Ketamine 1 mg/Kg.; Other Names: Ketamine hydrochloride
EXPERIMENTAL: Lidocaine-ketamine group; 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.	Drug: Midazolam; This group will receive midazolam 0.05 mg/Kg; Other Names: dormicum; Drug: ketamine half dose; This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.; Other Names: Ketamine hydrochloride; Drug: Lidocaine; This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.; Other Names: Lidocaine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial blood pressure	Mean arterial blood pressure measured in mmHg	10 minutes after induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Norepinephrine consumption	The total dose of norepinephrine measured in micrograms	10 minutes after induction of general anesthesia
Heart rate	Number of heart beats per minute	10 minutes after induction of general anesthesia
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
Cardiac output	Volume of blood pumped by the heart in one minute measured in liters per minute	10 minutes after induction of general anesthesia
Systolic blood pressure	Systolic arterial blood pressure measured in mmHg	10 minutes after induction of general anesthesia

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Ashraf Rady, Professor, Head of department of anesthesia, Cairo University, Egypt

Publications and helpful links

General Publications

• Fathy S, Hasanin A, Mostafa M, Ramzy E, Sarhan K, Almenesey T, Safina AG, Hosny O, Hamden GA, Gado AA, Mokhtar A. The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100731. doi: 10.1016/j.accpm.2020.06.017. Epub 2020 Sep 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2019
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 23, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Midazolam; Lidocaine
• Other Study ID Numbers: N128-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No