Protocol summary

Summary
In most rhinoplasty surgeries, a corticosteroid is used to reduce inflammatory complications. Due to the severe complications of rhinoplasty, this study was designed with the aim of comparing the three doses of dexamethasone with a single-dose of dexamethasone in reducing intraoperative bleeding, blood pressure, operation time, edema and ecchymosis due to rhinoplasty. Patients who are going to be studied are between 18 and 30 years old and do not have a history of diseases such as hypertension, heart diseases and diabetes, also they are not smokers or alcoholic either. In this clinical trial, among the candidates for rhinoplasty surgery, 100 patients will be selected and randomly be divided into two groups of 50 people. All patients will sign informed consent. This intervention about prescribing of drugs is so that only the doctor is aware of how to prescribe drugs. In both groups patients will be use the same venous dexamethasone ampoules(8 mg per kg). In the first group, a single dose will be injected before surgery and in the second group, three doses of dexamethasone will be injected so that the first dose will be taken like the first group, the second dose 8 hours after the operation, and the third dose 8 hours after the second injection. During the operation intraoperative bleeding, operation time, blood pressure and degree of eyelid edema and ecchymosis of the soft tissue around the eye will be recorded on the second day. In all patients, postoperative edema and ecchymosis, will be used a 0-4 scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011316195N1
Registration date: 2014-05-11, 1393/02/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Mohammad Khakzad
Name of organization / entity
Shahid Beheshti hospital
Country
Iran (Islamic Republic of)
Phone
+98 11 1225 6285
Email address
khakzad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Babol University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effect of three-doses of dexamethasone with a single-dose on intraoperative bleeding, blood pressure, operation time, edema and ecchymosis in patients who performed rhinoplasty.
Public title
Comparing the effect of three-doses of dexamethasone with a single-dose in reducing intraoperative bleeding, blood pressure, operation time, edema and ecchymosis induced by rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients are in the age range of 18 to 30 years; they do not have any history of diseases such as hypertension; heart diseases, diabetes; smoking or drinking alcohol. Exclusion criteria: Patients are not in the age range of 18 to 30 years; or have any history of diseases such as hypertension, heart diseases, diabetes; smoking or drinking alcohol.
Age
From 18 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences- Ganj afrooz Street- Babol- Iran
City
Babol
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
2306

Health conditions studied

1

Description of health condition studied
Plastic Surgery
ICD-10 code
Z41
ICD-10 code description
Procedures for purposes other than remedying health state

Primary outcomes

1

Description
Degree of eyelid edema
Timepoint
On the second day after surgery
Method of measurement
Clinical

2

Description
Ecchymosis of the soft tissue around the eyes
Timepoint
On the second day after surgery
Method of measurement
Clinical

3

Description
Operation time
Timepoint
During the operation
Method of measurement
Clinical

4

Description
Bleeding amount
Timepoint
During the operation
Method of measurement
Clinical

5

Description
Systolic and diastolic blood pressure
Timepoint
During the operation
Method of measurement
Clinical

Secondary outcomes

empty

Intervention groups

1

Description
Case group receive three doses of dexamethasone (8mg/kg), the first dose prior to surgery; Second dose inject 8 hours after surgery and the third dose carry 8 hours after the second injection.
Category
Treatment - Drugs

2

Description
In the case group before surgery, a single-dose of dexamethasone (8mg/kg) will be injected.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehregan Hospital
Full name of responsible person
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology of Babol University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Moghadamnia
Street address
Babol University of Medical Sciences- Ganj afrooz Street- Babol- Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Neda Amani
Position
Expert
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganj afrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 1225 6285
Fax
Email
neda_amani69@yahoo.com bcrdc90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Khakzad
Position
Plastic surgery subspecialist
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganj afrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 1225 2071
Fax
Email
khakzad@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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