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Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

Sponsor
Wahba bakhet (Other)
Overall Status
Completed
CT.gov ID
NCT04194294
Collaborator
Bahteem Specialized Hospital (Other)
70
Enrollment
2
Arms
45.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant is functioning correctly and determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Intravenous Lidocaine Reduces Remifentanil and Propofol Requirements Without Altering the Electrical Stapedial Reflex Threshold in Pediatric Cochlear Implants
Actual Study Start Date :
Aug 18, 2015
Actual Primary Completion Date :
Jun 5, 2019
Actual Study Completion Date :
Jun 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Liocaine

Group Lid

Drug: Lidocaine
Before induction of anesthesia; children in group LID received an iv bolus dose of LIDOCAINE 1 mg/kg over 5 minutes followed by 1 mg Kg-1 h-1 ivi until the start of skin closure.
Other Names:
  • Xylocaine

    		•
    Active Comparator: Na CL 0.9%

    group C

    Other: Na CL 0.9%
    Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of LIDOCAINE.
    Other Names:
  • isotonic saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Remifentanil consumption [at the end of the surgey]

      microgram per kilogram

    Secondary Outcome Measures

    1. ESRT responses [After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),]

      the surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    ASA I and II children

    Exclusion Criteria:

    uncontrolled hypertension, diabetes mellitus, liver disease, kidney disease, heart disease, allergy to lidocaine

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wahba bakhet
    • Bahteem Specialized Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wahba bakhet, Lectrure of anesthesia, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04194294
    Other Study ID Numbers:
    • LIDOCAINE-CI
    First Posted:
    Dec 11, 2019
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of May 1, 2020