The efficacy of preoperative single dose intravenous dexamethasone in decreasing the postparotidectomy facial nerve dysfunction rate in patients with benign superficial lobe of parotid tumor
In this clinical trial that will be unicentric, 40 Patients with benign parotid tumor with normal facial function and without deep parotid lobe involvement, will be selected and divided randomly and in double blind manner into two 20 person groups of drug (dexamethasone injection) and placebo (normal saline injection). Four hours before the parotid surgery, 8 mg of intravenous dexamethasone will be injected in patients of drug group and 2 ml of normal saline will be injected intravenously in patients of control (placebo) group. Then, all patients will undergo superficial parotidectomy. In the postoperative period, the efficacy of preoperative single dose intravenous dexamethasone in decreasing the facial nerve dysfunction rate and its relationship with the size, location and type of the tumor will be evaluated. In the case of nerve palsy, the nerve recovery time and the involved branches will be examined in both drug and placebo groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060823594N2
Registration date:2016-07-12, 1395/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Mehrnoush Mousavi-Aghdas
Name of organization / entity
Department of Otolaryngology, Children Hospital, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41333355921
Email address
mousavim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of preoperative single dose intravenous dexamethasone in decreasing the postparotidectomy facial nerve dysfunction rate in patients with benign superficial lobe of parotid tumor
Public title
The efficacy of preoperative single dose intravenous dexamethasone in decreasing the postparotidectomy facial nerve dysfunction rate in patients with benign superficial lobe of parotid tumor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with benign parotid tumor and normal facial nerve function
Exclusion criteria: patients with history of diabetes mellitus; history of autoimmune diseases; sensitivity to corticosteroids and other contraindications of these medicines; history of corticosteroid use; tumor spread to deep lobe; history of previous surgery of the parotid; history of face and neck radiotherapy; history of malignant disease in parotid gland and face; and preoperative facial nerve dysfunction in each branch
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabrizl University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2016-06-07, 1395/03/18
Ethics committee reference number
ir.tbzmed.rec.1395.165
Health conditions studied
1
Description of health condition studied
Facial nerve dysfunction
ICD-10 code
SO4.5
ICD-10 code description
Injury of facial nerve
Primary outcomes
1
Description
Facial nerve dysfunction
Timepoint
First day, one week and one month after the surgery
Method of measurement
Physical exam
Secondary outcomes
1
Description
Involved branches of facial nerve
Timepoint
First day, one week and one month after the surgery
Method of measurement
Physical exam
2
Description
Size of tumor
Timepoint
After surgery
Method of measurement
Lab
3
Description
Histologic type of tumor
Timepoint
After surgery
Method of measurement
Lab
4
Description
Position of tumor
Timepoint
During surgery
Method of measurement
Visual
Intervention groups
1
Description
Eight milligrams of intravenous dexamethasone injection in the patients of drug (intervention) group 4 hours before the parotidectomy
Category
Treatment - Drugs
2
Description
Two milliliters of normal saline intravenous injection in the patients of placebo (control) group 4 hours before the parotidectomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT (Otolaryngorhinology) Department, Imam Reza Hospital
Full name of responsible person
Dr. Kasra Tavassoli
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kasra Tavassoli
Position
ENT (Otolaryngorhinology) assistant
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
kasra364@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoush Mousavi Aghdas
Position
Otolaryngorhinologist
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
mehr_mousavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoush Mousavi Aghdas
Position
Otolaryngorhinologist
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)