Evaluation of therapeutic effect of nimodipine on facial nerve injury following cerebellopeduncular angle tumor surgery
Design
The subjects will be placed on the first day of postoperative post-PO surgery and will be allowed to start feeding or gavage under the semi-mediastin with g60 every 6 hours. The first fallopian is 3 times and then 6 months after the surgery. The recovery pattern of the facial nerve is based on House-Brackmann Score and will be evaluated and recorded.
Settings and conduct
The study will be conducted as a blind clinical trial. The site of the study will be Imamreza Hospital.
Participants/Inclusion and exclusion criteria
Patients with CPA tumor in Tabriz Imam Reza Hospital will undergo surgery in the neurosurgery department and will be operated in the lateral position and with the retro-sigmoid approach. People who have a clear cut of nerves during surgery will be excluded from the study.
Intervention groups
Intervention group: The subjects will be placed on the first day of postoperative post-PO surgery and will be allowed to start feeding or gavage under the condition of norepinephrine with g60 every 6 hours. The first fallopian is 3 times and then 6 months after the surgery.
Main outcome variables
The recovery pattern of the facial nerve is based on House-Brackmann Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N8
Registration date:2019-06-12, 1398/03/22
Registration timing:prospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of nimodipine on facial nerve injury following cerebellar peduncle angle tumor surgery
Public title
Evaluation of therapeutic effect of nimodipine on facial nerve injury following brain tumor surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with CP angle tumor with diameter less than 3 cm and postoperative facial weakness
Satisfaction to participate in the study
Exclusion criteria:
Facial weakness before surgery
Complete nerve disruption during surgery
Large tumor diameter (over 3 cm)
Tumors other than schwannoma and meningioma
Age
To 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Floor 3, Center building N 2, Tabriz university of medical sciences, Golgasht street.
City
Tabriz
Province
East Azarbaijan
Postal code
04133357310
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.TBZMED.REC.1398.201
Health conditions studied
1
Description of health condition studied
Faintal nerve weakness after surgery
ICD-10 code
S04.5
ICD-10 code description
Injury of facial nerve
Primary outcomes
1
Description
The recovery pattern of the nasal fascia
Timepoint
After discharge from the operating room, 3 and 6 months after surgery
Method of measurement
House-Brackmann Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Subjects will be placed on the first day of postoperative post-PO surgery and will be allowed to start feeding or gavage under the semi-mediastin with g60 every 6 hours. The first fallopian is 3 times and then 6 months after the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Mohammad Kazemzadeh Yaghouti Nobar
Street address
Imamreza Hospital, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Kazemzadeh Yaghouti Nobar
Street address
Vice Chancellor for Research , Faculty of Medicine , Gholghasht Street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Fax
+98 41 3337 6923
Email
info@medfac.tbzmed.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?