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

NCT04148534 | Completed

• 1 other identifier: D-4-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebellopontine Angle Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• number of hypotension episodes and the use of vasopressors

  6 to 8 month

• Total volume of propofol and fentanyl infused

  6 to 8 month

Study Arms (2)

muscle relaxant

ACTIVE COMPARATOR

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

without muscle relaxant

PLACEBO COMPARATOR

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

Drug: Rocroniom, Non Depolarizing Muscle Relaxant

Interventions

Rocroniom, Non Depolarizing Muscle Relaxant DRUG

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

Also known as: Nerve stimulator for train of four assessment, BIS bispectral index

muscle relaxant; without muscle relaxant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Magdy Gaber: lead
• Cairo University: collaborator

Study Sites (1)

Cairo university medical school

Cairo, Egypt

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Cairo university

  Cairo university faculty of medicine research ethical committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass lecturer

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: November 1, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)