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Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery

W

Wahba bakhet

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Lidocaine
Other: Na CL 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT04194294
LIDOCAINE-CI

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

6 months to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

ASA I and II children

Exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

70 participants in 2 patient groups

Liocaine
Active Comparator group
Description:
Group Lid
Treatment:
Drug: Lidocaine
Na CL 0.9%
Active Comparator group
Description:
group C
Treatment:
Other: Na CL 0.9%

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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