NCT04194294

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

December 9, 2019

Last Update Submit

April 30, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Remifentanil consumption

    microgram per kilogram

    at the end of the surgey

Secondary Outcomes (1)

  • ESRT responses

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

Study Arms (2)

Liocaine

ACTIVE COMPARATOR

Group Lid

Drug: Lidocaine

Na CL 0.9%

ACTIVE COMPARATOR

group C

Other: Na CL 0.9%

Interventions

LidocaineDRUG

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.

Also known as: Xylocaine
Liocaine
Na CL 0.9%OTHER

Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of LIDOCAINE.

Also known as: isotonic saline solution
Na CL 0.9%

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lectrure of anesthesia

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

August 18, 2015

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

May 1, 2020

Record last verified: 2020-04