Comparison of the amount of bleeding during septorhinoplasty in the group receiving Oxymetazoline nasal spray compared to the control group without receiving Oxymetazoline nasal spray.
Design
Randomized controlled, parallel-group, unblinded, phase 2-3 clinical trial on 30 patients. The randomization method will be''Random Allocation'' computer software.
Settings and conduct
The statistical population in this study consists of patients who are candidates for septorhinoplasty surgery who visited the Arad Ardabil surgery center between July 2023 and the end of December 2023 and underwent surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria included being a candidate for septorhinoplasty surgery, ASA one or two, and having consent to participate in the study. Exclusion criteria include having sensitivity to Oxymetazoline.
Intervention groups
For patients in the case group, two puffs of Oxymetazoline nasal spray will be used 5 minutes before the start of septorhinoplasty, while in the control group, no intervention was performed and they will be under routine care.
Main outcome variables
Patient's gender, patient's age, surgeon's satisfaction with the surgical field, patients' systolic and diastolic blood pressure before induction of anesthesia and after intubation and at the end of surgery, heart rate, bleeding rate, use of secondary antihypertensive drugs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058190N1
Registration date:2023-06-25, 1402/04/04
Registration timing:prospective
Last update:2023-06-25, 1402/04/04
Update count:0
Registration date
2023-06-25, 1402/04/04
Registrant information
Name
Hossein Farzaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 1255
Email address
hossein.frz96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Oxymetazoline nasal spray on septorhinoplasty surgery bleeding
Public title
Effect of Oxymetazoline on septorhinoplasty surgery bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for septorhinoplasty surgery
ASA one or two
Consent to participate in the study
Exclusion criteria:
Being allergic to Oxymetazoline
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
30 eligible patients will be selected randomly. Then these people will be randomly encoded using computer software called ''Random Allocation'' and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of two intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Ardabil Branch
Street address
Basij square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Approval date
2023-02-07, 1401/11/18
Ethics committee reference number
IR.IAU.ARDABIL.REC.1402.003
Health conditions studied
1
Description of health condition studied
Bleeding in septorhinoplasty surgery
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Bleeding rate
Timepoint
During septorhinoplasty surgery
Method of measurement
Measuring the blood in the suction device
2
Description
Systolic and diastolic blood pressure
Timepoint
Before induction of anesthesia, after intubation and at the end of surgery
Method of measurement
Monitoring device
3
Description
Heart rate
Timepoint
Before induction of anesthesia, after intubation and at the end of surgery
Method of measurement
Monitoring device
Secondary outcomes
1
Description
Surgeon's satisfaction with the surgical field
Timepoint
After completion of septorhinoplasty surgery
Method of measurement
According to the opinion of the surgeon who performed the septorhinoplasty surgery
Intervention groups
1
Description
Intervention group: For patients in the case group, two puffs of Oxynose Nasal Spray made by Raha Pharmaceutical Company, which contains Oxymetazoline Hydrochloride 0.05%, will be used 5 minutes before the start of septorhinoplasty.
Category
Prevention
2
Description
Control group:In the control group, no intervention will be done and they will be under routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arad Ardabil Surgery Center
Full name of responsible person
Dr.Raof Mollajavadi
Street address
Motahari street, Yahyavi square
City
Ardabil
Province
Ardabil
Postal code
5613943311
Phone
+98 914 351 2832
Email
mollajavadi.r@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Raof Mollajavadi
Street address
Basij square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
mollajavadi.r@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Farzaneh
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.103, North Hojati alley ,16 meter Omid street, Hafez street
City
Ardabil
Province
Ardabil
Postal code
5615743339
Phone
+98 45 3372 1255
Email
hossein.frz96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Raof Mollajavadi
Position
Non-academic specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Basij square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
mollajavadi.r@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Farzaneh
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.103, North Hojati alley ,16 meter Omid street, Hafez street
City
Ardabil
Province
Ardabil
Postal code
5615743339
Phone
+98 45 3372 1255
Email
hossein.frz96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The majority of participants agreed to participate if the confidentiality of data would be guaranteed, given the type of surgery they would undergo.