Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194294
• Other study ID #: LIDOCAINE-CI
• Status: Completed
• Phase: Phase 4
• Start date: August 18, 2015
• Est. completion date: June 5, 2019

Study information

• Verified date: April 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

ASA I and II children

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	bahteem specialized hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil consumption	microgram per kilogram	at the end of the surgey
Secondary	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),