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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

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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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