search
Back to results

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

Primary Purpose

Cerebellopontine Angle Tumor

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rocroniom, Non Depolarizing Muscle Relaxant
Sponsored by
Muhammad Magdy Gaber
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cerebellopontine Angle Tumor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Cairo university medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

muscle relaxant

without muscle relaxant

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

number of hypotension episodes and the use of vasopressors
hemodynamic condition
Total volume of propofol and fentanyl infused
Calculate dose consumption

Full Information

First Posted
October 25, 2019
Last Updated
June 23, 2022
Sponsor
Muhammad Magdy Gaber
Collaborators
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04148534
Brief Title
Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery
Official Title
Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Magdy Gaber
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellopontine Angle Tumor

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
muscle relaxant
Arm Type
Active Comparator
Arm Description
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)
Arm Title
without muscle relaxant
Arm Type
Placebo Comparator
Arm Description
patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60.
Intervention Type
Drug
Intervention Name(s)
Rocroniom, Non Depolarizing Muscle Relaxant
Other Intervention Name(s)
Nerve stimulator for train of four assessment, BIS bispectral index
Intervention Description
compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery
Primary Outcome Measure Information:
Title
End to start facial nerve MEP amplitude ratio.
Description
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.
Time Frame
6 to 8 month
Secondary Outcome Measure Information:
Title
number of hypotension episodes and the use of vasopressors
Description
hemodynamic condition
Time Frame
6 to 8 month
Title
Total volume of propofol and fentanyl infused
Description
Calculate dose consumption
Time Frame
6 to 8 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cairo university
Organizational Affiliation
Cairo university faculty of medicine research ethical committee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university medical school
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs