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Clinical Trials/NCT04194294
NCT04194294
Completed
Phase 4

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

Wahba bakhet0 sites70 target enrollmentAugust 18, 2015
ConditionsAnesthesia
InterventionsNa CL 0.9%Lidocaine

Overview

Phase
Phase 4
Intervention
Na CL 0.9%
Conditions
Anesthesia
Sponsor
Wahba bakhet
Enrollment
70
Primary Endpoint
Remifentanil consumption
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2015
End Date
June 5, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wahba bakhet
Responsible Party
Sponsor Investigator
Principal Investigator

Wahba bakhet

Lectrure of anesthesia

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • ASA I and II children

Exclusion Criteria

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

Arms & Interventions

Na CL 0.9%

group C

Intervention: Na CL 0.9%

Liocaine

Group Lid

Intervention: Lidocaine

Outcomes

Primary Outcomes

Remifentanil consumption

Time Frame: at the end of the surgey

microgram per kilogram

Secondary Outcomes

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

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