Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

Intravenous Lidocaine Reduces Remifentanil and Propofol Requirements Without Altering the Electrical Stapedial Reflex Threshold in Pediatric Cochlear Implants

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Lidocaine; Other: Na CL 0.9%

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

ASA I and II children

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil consumption	microgram per kilogram	at the end of the surgey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESRT responses	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	After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),

Collaborators and Investigators

• Sponsor: Wahba bakhet
• Collaborators: Bahteem Specialized Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2015
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: LIDOCAINE-CI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No