Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients

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ClinicalTrials.gov Identifier: NCT03640468

Recruitment Status : Unknown

Verified November 2018 by Ahmed Hasanin, Cairo University.
Recruitment status was: Not yet recruiting

First Posted : August 21, 2018

Last Update Posted : November 21, 2018

Sponsor:

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 Anesthesia	Drug: Ketamine full dose Drug: Ketamine half dose Drug: Lidocaine Drug: Midazolam Drug: Normal saline	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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
Estimated Study Start Date :	December 20, 2018
Estimated Primary Completion Date :	June 15, 2019
Estimated Study Completion Date :	July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Drug Information available for: Lidocaine hydrochloride Lidocaine Ketamine

U.S. FDA Resources

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: 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 Other Name: Lidocaine Hydrochloride Drug: Midazolam This group will receive midazolam 0.05 mg/Kg Other Name: Dormicum

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Heart rate [ Time Frame: 10 minutes after induction of general anesthesia ]
number of heart beats per minutes
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
The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia [ Time Frame: 10 minutes after induction of general anesthesia ]
Norepinephrine consumption [ Time Frame: 10 minutes after induction of general anesthesia ]
The total dose of norepinephrine measured in micrograms

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640468

Contacts

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Contact: Sarah Amin, Lecturer	+201227476617	sarahamin_22@hotmail.com

Locations

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Egypt
Cairo University
Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

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Principal Investigator:	Ahmed Hasanin, Professor	Assistant professor of anesthesia

More Information

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Responsible Party:	Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
ClinicalTrials.gov Identifier:	NCT03640468
Other Study ID Numbers:	N-128-2018
First Posted:	August 21, 2018 Key Record Dates
Last Update Posted:	November 21, 2018
Last Verified:	November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Additional relevant MeSH terms:

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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

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