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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04194294

Enrollment

Registered

2019-12-11

Start date

2015-08-18

Completion date

2019-06-05

Last updated

2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

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.

Interventions

DRUGLidocaine

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.

OTHERNa 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026