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

June 23, 2022 updated by: Muhammad Magdy Gaber

Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo university medical school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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)
Drug: 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
Other Names:
  • Nerve stimulator for train of four assessment
  • BIS bispectral index
PLACEBO_COMPARATOR: without muscle relaxant
patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60.
Drug: 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
Other Names:
  • Nerve stimulator for train of four assessment
  • BIS bispectral index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End to start facial nerve MEP amplitude ratio.
Time Frame: 6 to 8 month
TCMEP recording will begin (1) prior to skin incision as baseline amplitude before muscle relaxant be taken for intubation (2) at Dural closure and end \start amplitude ratio will be calculated.
6 to 8 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of hypotension episodes and the use of vasopressors
Time Frame: 6 to 8 month
hemodynamic condition
6 to 8 month
Total volume of propofol and fentanyl infused
Time Frame: 6 to 8 month
Calculate dose consumption
6 to 8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Magdy Gaber

Collaborators

Cairo University

Investigators

  • Principal Investigator: Cairo university, Cairo university faculty of medicine research ethical committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

November 15, 2020

Study Completion (ACTUAL)

November 15, 2020

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (ACTUAL)

November 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-4-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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