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Completed

NCT Number: NCT04148534

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university medical school

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Other names: Nerve stimulator for train of four assessment, BIS bispectral index

Primary outcomes

  1. 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.

Secondary outcomes

  1. number of hypotension episodes and the use of vasopressors

    Time frame: 6 to 8 month

    hemodynamic condition

  2. Total volume of propofol and fentanyl infused

    Time frame: 6 to 8 month

    Calculate dose consumption

Sponsors and collaborators

Lead sponsor

Muhammad Magdy Gaber

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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