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

Cerebellopontine Angle Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148534
• Other study ID #: D-4-2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Cerebellopontine Angle Tumor
• Neuroma, Acoustic

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university medical school	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Muhammad Magdy Gaber	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 to 8 month
Secondary	number of hypotension episodes and the use of vasopressors	hemodynamic condition	6 to 8 month
Secondary	Total volume of propofol and fentanyl infused	Calculate dose consumption	6 to 8 month