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A Dose-response Study of Lidocaine and Etomidate

Primary Purpose

Etomidate Overdose of Undetermined Intent

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lidocaine 1mg/kg
Lidocaine 1.5mg/kg
Lidocaine 2mg/kg
Lidocaine 2.5mg/kg
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Etomidate Overdose of Undetermined Intent focused on measuring iv lidocaine, inducing dose, etomidate, dose response

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients scheduled for Elective Surgery,
  2. age limit within 18-70 years,
  3. American Society of Anaesthesiologists physical status classification I-II

Exclusion Criteria:

  1. Adrenal Cortex disorder,
  2. Neurologic disease,
  3. Psychiatric disorders,
  4. Allergic to Local anesthetic drugs,
  5. Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Control

    Lidocaine 1mg/kg

    Lidocaine 1.5mg/kg

    Lidocaine 2mg/kg

    Lidocaine 2.5mg/kg

    Arm Description

    0.9% Normal Saline is given instead of Lidocaine in the same volume and duration. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

    Lidocaine 1mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

    Lidocaine 1.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

    Lidocaine 2mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

    Lidocaine 2.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.

    Outcomes

    Primary Outcome Measures

    changes in blood pressure and heart rate.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2013
    Last Updated
    August 1, 2013
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01916642
    Brief Title
    A Dose-response Study of Lidocaine and Etomidate
    Official Title
    Can Intravenous Lidocaine Decrease the Minimal Inducing Dose of Etomidate?: A Randomized Placebo-controlled Dose-response Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction of anesthesia.
    Detailed Description
    The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All the patients were informed in detail about the procedure and the medications they are going to get. Patients are well informed about the beneficial and possible hazards of the medicines and procedure. Patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. Patients' written informed consent was obtained and registered for the permission from the Hospital's Ethics Board.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Etomidate Overdose of Undetermined Intent
    Keywords
    iv lidocaine, inducing dose, etomidate, dose response

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    0.9% Normal Saline is given instead of Lidocaine in the same volume and duration. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
    Arm Title
    Lidocaine 1mg/kg
    Arm Type
    Active Comparator
    Arm Description
    Lidocaine 1mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
    Arm Title
    Lidocaine 1.5mg/kg
    Arm Type
    Active Comparator
    Arm Description
    Lidocaine 1.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
    Arm Title
    Lidocaine 2mg/kg
    Arm Type
    Active Comparator
    Arm Description
    Lidocaine 2mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
    Arm Title
    Lidocaine 2.5mg/kg
    Arm Type
    Active Comparator
    Arm Description
    Lidocaine 2.5mg/kg is given intravenously within 2 minutes. Then, Etomidate 2mg intravenously every 15 seconds is given until the complete loss of consciousness as detected as the complete loss of eyelash reflex.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 1mg/kg
    Other Intervention Name(s)
    Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
    Intervention Description
    The total dosage of Etomidate needed for induction of anesthesia is recorded at last.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 1.5mg/kg
    Other Intervention Name(s)
    Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
    Intervention Description
    same as other
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 2mg/kg
    Other Intervention Name(s)
    Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
    Intervention Description
    same as other
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 2.5mg/kg
    Other Intervention Name(s)
    Lidocaine, serial number:1303E11, Etomidate-Lipuro, serial number:11215033
    Intervention Description
    same as other
    Primary Outcome Measure Information:
    Title
    changes in blood pressure and heart rate.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for Elective Surgery, age limit within 18-70 years, American Society of Anaesthesiologists physical status classification I-II Exclusion Criteria: Adrenal Cortex disorder, Neurologic disease, Psychiatric disorders, Allergic to Local anesthetic drugs, Patients who have received sedatives,analgesics or opioids within the previous 24 hrs.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liu Jin, MD
    Organizational Affiliation
    West China Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Dose-response Study of Lidocaine and Etomidate

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