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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04148534
Other study ID # D-4-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04249921 - Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
Not yet recruiting NCT03228511 - Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions N/A