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

Sponsor
Muhammad Magdy Gaber (Other)
Overall Status
Completed
CT.gov ID
NCT04148534
Collaborator
Cairo University (Other)
40
Enrollment
1
Location
2
Arms
12.5
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rocroniom, Non Depolarizing Muscle Relaxant
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Screening
Official Title:
Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Nov 15, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. End to start facial nerve MEP amplitude ratio. [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 Outcome Measures

    1. number of hypotension episodes and the use of vasopressors [6 to 8 month]

      hemodynamic condition

    2. Total volume of propofol and fentanyl infused [6 to 8 month]

      Calculate dose consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo university medical school Cairo Egypt

    Sponsors and Collaborators

    • Muhammad Magdy Gaber
    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muhammad Magdy Gaber, Ass lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04148534
    Other Study ID Numbers:
    • D-4-2019
    First Posted:
    Nov 1, 2019
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroma, Acoustic
    Neuromuscular Nondepolarizing Agents

    Study Results

    No Results Posted as of Jun 29, 2022