Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery

NCT ID: NCT04148534

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-11-15

Brief Summary

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compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .

* To Estimate End to start facial nerve MEP amplitude ratio
* To determine the effect of neuromuscular relaxant degrees on recovery and
* Assessment of propofol doses needed for enhancement of early recovery and ambulation.

Detailed Description

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40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.

Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.

Conditions

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Cerebellopontine Angle Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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muscle relaxant

patient who will receive muscle relaxant, patients will receive rocronium infusion by (5 mcg/kg/min) , maintain partial NMB TOF count 2 and targeting BIS = (40-60)

Group Type ACTIVE_COMPARATOR

Rocroniom, Non Depolarizing Muscle Relaxant

Intervention Type DRUG

compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery

without muscle relaxant

patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60.

Group Type PLACEBO_COMPARATOR

Rocroniom, Non Depolarizing Muscle Relaxant

Intervention Type DRUG

compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery

Interventions

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Rocroniom, Non Depolarizing Muscle Relaxant

compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery

Intervention Type DRUG

Other Intervention Names

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Nerve stimulator for train of four assessment BIS bispectral index

Eligibility Criteria

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Inclusion Criteria

* Patients age between \>18 and\<60.
* Patients scheduled for neurosurgical CPA surgeries
* Ability to sign the consent
* ASA classification I, II

Exclusion Criteria

* ASA \> II
* Hemodynamically unstable
* Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
* GCS \< 15.
* Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Muhammad Magdy Gaber

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Magdy Gaber

Ass lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cairo university

Role: PRINCIPAL_INVESTIGATOR

Cairo university faculty of medicine research ethical committee

Locations

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Cairo university medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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D-4-2019

Identifier Type: -

Identifier Source: org_study_id

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