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

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: Cerebellopontine Angle Tumor
• Intervention / Treatment: Drug: Rocroniom, Non Depolarizing Muscle Relaxant

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

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university medical school

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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	hemodynamic condition	6 to 8 month
Total volume of propofol and fentanyl infused	Calculate dose consumption	6 to 8 month

Collaborators and Investigators

• Sponsor: Muhammad Magdy Gaber
• Collaborators: Cairo University
• Investigators: Principal Investigator: Cairo university, Cairo university faculty of medicine research ethical committee

Study record dates

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: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neurilemmoma; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuroma, Acoustic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Nondepolarizing Agents
• 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