Clinical Trials Directory

Trials / Completed

CompletedNCT04194294

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
Phase
Phase 4
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Wahba bakhet · Academic / Other
Sex
All
Age
6 Months – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLidocaineBefore 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.

Timeline

Start date
2015-08-18
Primary completion
2019-06-05
Completion
2019-06-05
First posted
2019-12-11
Last updated
2020-05-01

Source: ClinicalTrials.gov record NCT04194294. Inclusion in this directory is not an endorsement.