Objectives: The purpose of this study is to evaluate the effect of phenylephrine spray is closed reduction of nasal bones fracture in patients referred to the ENT clinic of ValiAsr hospital.
Design: The sample size of this study will be 200 people, including 100 cases and 100 cases as control group. The patients will be randomly assigned to each group by using A and B papers by patients.
Setting and conduct: Patients will receive pre-anesthesia phenylephrine spray. Blood pressure of all patients before and 5 minutes after the intervention will be measured.
Major inclusion and exclusion criteria: All patients with recent nasal bones fractures will be included in the study and patients with septal fractures, open fractures and upper airways infection will be excluded.
Intervention: Using phenylephrine spray pre-anesthesia.
Main outcome measures (variables): Mean blood pressure before and 5 minutes after the operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030518063N3
Registration date:2016-04-01, 1395/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Ali Rajabpour Sanati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1067
Email address
ali.poursanati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Birjand University of Medical Sciences
Expected recruitment start date
2016-03-15, 1394/12/25
Expected recruitment end date
2016-05-15, 1395/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of phenylephrine spray in patients with nasal fractures closed reduction under general anesthesia
Public title
The effects of phenylephrine spray in patients with nasal fractures closed reduction under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Recent untreated nasal bones fracture
Exclusion Criteria: Septum fracture; Open fractures; Along with other facial bones broken nose; Conflict or infection of the sinuses; Colds and upper respiratory tract infection
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
دانشگاه علوم پزشکی بیرجند
Secondary trial Id
767
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Postal code
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
ir.byms.1394.53
Health conditions studied
1
Description of health condition studied
Nasal Bone Fractures
ICD-10 code
S02.2
ICD-10 code description
Fracture of nasal bones
Primary outcomes
1
Description
Mean Blood Pressure
Timepoint
before intervention - 5 minutes after surgery
Method of measurement
Vital Sign Monitoring
Secondary outcomes
1
Description
---
Timepoint
---
Method of measurement
---
Intervention groups
1
Description
case group: treated with phenylephrine spray 30 minutes before undergoing surgery
Category
Treatment - Drugs
2
Description
control group: the patients in this group will not take phenylephrine spray before surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Hospital
Full name of responsible person
Fahime Gohari
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research - Birjand University of Medical Sciences
Full name of responsible person
Dr. Zarban
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research - Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Fahimeh Gohari
Position
Medical Student
Other areas of specialty/work
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Postal code
379-97175
Phone
+98 56 3244 3000
Fax
Email
fahimeh.gohari@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Mofateh
Position
Assistant Professor
Other areas of specialty/work
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Postal code
379-97175
Phone
+98 56 3244 3000
Fax
Email
m.mofateh@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahimeh Gohari
Position
Medical Student
Other areas of specialty/work
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Postal code
379-97175
Phone
+98 56 3244 3000
Fax
Email
Fahimeh.gohari@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)