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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

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE February 20, 2019
Actual Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
Mean arterial blood pressure [ Time Frame: 10 minutes after induction of general anesthesia ]
Mean arterial blood pressure measured in mmHg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • Heart rate [ Time Frame: 10 minutes after induction of general anesthesia ]
    Number of heart beats per minute
  • 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
  • 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
  • Norepinephrine consumption [ Time Frame: 10 minutes after induction of general anesthesia ]
    The total dose of norepinephrine measured in micrograms
  • Systolic blood pressure [ Time Frame: 10 minutes after induction of general anesthesia ]
    Systolic arterial blood pressure measured in mmHg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients
Official Title  ICMJE Lidocaine-Ketamine Versus Ketamine for Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: ketamine full dose
    • Drug: Midazolam
    • Drug: Normal saline
  • 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.
    Interventions:
    • Drug: Midazolam
    • Drug: ketamine half dose
    • Drug: Lidocaine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2019)
43
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2019)
40
Actual Study Completion Date  ICMJE September 20, 2019
Actual Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients under 18 years
  • Burn patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03844984
Other Study ID Numbers  ICMJE N128-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ahmed Hasanin, Cairo University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cairo University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ashraf Rady, Professor Head of department of anesthesia, Cairo University, Egypt
PRS Account Cairo University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP