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
About this trial
This is an interventional screening trial for Cerebellopontine Angle Tumor
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.)
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
NCT ID
NCT04148534
First Posted
October 25, 2019
Last Updated
June 23, 2022
Sponsor
Muhammad Magdy Gaber
Collaborators
Cairo University
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
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