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Trial record 1 of 1 for:    NCT03844984
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Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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




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



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

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): NCT03844984


Locations
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Egypt
Ahmed Mohamed Hasanin
Cairo, Egypt, 11432
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ashraf Rady, Professor Head of department of anesthesia, Cairo University, Egypt
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
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