Skip to main content
OpenTrials
Completed

NCT Number: NCT04194294

Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ASA I and II children

Exclusion criteria

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

Treatment and study plan

Lidocaine

Drug

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

Na CL 0.9%

Other

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

Primary outcomes

  1. Remifentanil consumption

    Time frame: at the end of the surgey

    microgram per kilogram

Secondary outcomes

  1. ESRT responses

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • Bahteem Specialized Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2019
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.