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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

Tracking Information
First Submitted Date  ICMJE August 18, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date November 21, 2018
Estimated Study Start Date  ICMJE December 20, 2018
Estimated Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
Mean arterial pressure [ Time Frame: 10 minutes after induction of general anesthesia ]
Mean arterial pressure measured in mmHg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • 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
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 as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients
Official Title  ICMJE Lidocaine as an Adjuvant for Ketamine in 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
  • Anesthesia
Intervention  ICMJE
  • Drug: Ketamine full dose
    This group will receive induction of anesthesia using Ketamine 1 mg/Kg
    Other Name: Ketamine hydrochloride
  • 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
  • Drug: Normal saline
    This group will receive normal saline 10 mL
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: Ketamine half dose
    • Drug: Lidocaine
    • Drug: Midazolam
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
30
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 15, 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 NCT03640468
Other Study ID Numbers  ICMJE N-128-2018
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
Responsible Party Ahmed Hasanin, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Hasanin, Professor Assistant professor of anesthesia
PRS Account Cairo University
Verification Date November 2018

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