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

• ClinicalTrials.gov Identifier: NCT03844984
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: November 26, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Hasanin, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Septic Shock	Drug: ketamine full dose; Drug: Midazolam; Drug: Normal saline; Drug: ketamine half dose; Drug: Lidocaine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
• Actual Study Start Date: February 20, 2019
• Actual Primary Completion Date: September 20, 2019
• Actual Study Completion Date: September 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean arterial blood pressure [ Time Frame: 10 minutes after induction of general anesthesia ]
   Mean arterial blood pressure measured in mmHg

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under 18 years
• Burn patients

Contacts and Locations

Locations

Egypt

Ahmed Mohamed Hasanin

Cairo, Egypt, 11432

Sponsors and Collaborators

Cairo University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
• ClinicalTrials.gov Identifier: NCT03844984
• Other Study ID Numbers: N128-2018
• First Posted: February 19, 2019
• Last Update Posted: November 26, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Lidocaine; Midazolam; Ketamine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Analgesics; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives