Protocol summary

Study aim
Comparison of the Effects of Desmopressin, Phenylephrine and Tranexamic Acid Locally on the Amount of Bleeding and the Field of View of the Surgeon During Rhinoplasty Surgery
Design
Clinical Trial with a Control Group, with Parallel Groups, Three Blinded, Randomized, Phase 3 on 96 Diseases
Settings and conduct
This Study Will Be Conducted in Hamadan Ba'ath Hospital. This Is a Triple-Blind Study Where the Participants, the Researcher and the Surgeon Are Blinded to the Study. Bleeding Rate Will Be Measured Through Blood Gases and Suction Bottle, and Surgeon's Satisfaction with the Surgical Field Will Be Measured Through Boezaart Scale.
Participants/Inclusion and exclusion criteria
Entry Conditions Include Patients' Age and Standard Laboratory Results. Exit Conditions Include Not Consuming Alcohol, Vitamin E and Aspirin in the Last 1 Week. Also, Patients Should Not Have High Blood Pressure, Brain Diseases, Cardiovascular Diseases, Coagulation Problems, Morbid Obesity, Smoking and Addiction. Patients Who Have a Severe Osteotomy According to the Surgeon, Whose Surgery Takes More Than 2 Hours, and Who Suffer Severe Hypotension During Surgery, Are Excluded from the Study.
Intervention groups
The Desmopressin Group Will Receive Two Puffs of Desmex Nasal Spray (40 Micrograms) in Each Nostril 30 Minutes Before Surgery. Tranexamic Acid Group, We Will Break One Tranexip 500 Milligram (Mg) Ampoule and Dip Two 10 Centimeter (Cm) Tampons in It and Place It Inside Each Nostril. for Each Person, Phenylephrine Group, 40 Drops of 0.25% Phenylephrine Are Poured on 2 Tampons of 10 Cm and We Place the Soaked Tampon into Each Nostril. The Control Group Will Receive Two 10 Cm Tampons Soaked in 0.9% Normal Saline in Each Nostril.
Main outcome variables
Reduction of bleeding during surgery followed by reduction of swelling and ecchymosis after surgery. Surgeon's satisfaction with the surgical field

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240712062409N1
Registration date: 2024-07-21, 1403/04/31
Registration timing: prospective

Last update: 2024-07-21, 1403/04/31
Update count: 0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Mohammad Reza Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 2979
Email address
lvlre1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effect of Topical Desmopressin, Phenylephrine and Tranexamic Acid on the Amount of Bleeding and the Field of Vision of the Surgeon During Rhinoplasty Surgery: A Three-blind Clinical Trial Study
Public title
Effect of Topical Desmopressin, Phenylephrine and Tranexamic Acid on the Amount of Bleeding and the Surgeon's Visual Field During Rhinoplasty Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 Patient Satisfaction Normal Hemoglobin Normal Prothrombin Time Normal Partial Thromboplastin Time Normal Platelets Normal Hematocrit
Exclusion criteria:
Alcohol Consumption in the Last Week Smoking and Addiction Aspirin and Vitamin E Consumption in the Last Week Cardiovascular Diseases Coagulation Problems High Blood Pressure Diabetes Brain Diseases Morbid Obesity Severe Hypotension During Surgery Patients Who Require Severe Osteotomy from the Surgeon's Point of View Surgery Time more than 2 Hours
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are Divided by the Method of Eight Random Blocks, which will be Randomly Assigned to One of Four Groups A, B, C, and D. Randomization was Performed by Means of PASS Software Version 11.
Blinding (investigator's opinion)
Triple blinded
Blinding description
We Introduce to the Participants the Drugs Used in the Study and Tell them that the Purpose of Using these Drugs is to Reduce the Amount of Bleeding During Surgery, which have been Used Alone in Other Studies, but their Effects have not been Compared with each Other Study, We Seek to Compare the Effect of these Drugs and Get Satisfaction from the Participants. The Surgeon who is Present in the Study will not know the Type of Drug Used, and before the Surgeon Enters the Operating Room, the Drug is Used, and Inside the Room, Only the Person who Collects the Data is Aware of the Type of Drug Used. The Researcher is not Responsible for Data Collection and Someone from the Treatment Staff who is Outside the Study is Responsible for this Task. The Data Analyst is Given Information in which the Type of Drugs is not Clear and even the Order of Letters of the Groups is Changed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Rokni Street, Shahid Paknia Alley, Magdiya Building 2
City
Hamedan
Province
Hamadan
Postal code
6516795679
Approval date
2024-07-20, 1403/04/30
Ethics committee reference number
IR.UMSHA.REC.1403.233

Health conditions studied

1

Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Deviation of the septum
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum

Primary outcomes

1

Description
Bleeding Rate
Timepoint
15, 30, 45 and 90 Minutes After Using the Drug During Surgery
Method of measurement
Blood Gas Weight and Suction Bottle Measurement

2

Description
Field of Vision of the Surgeon
Timepoint
15, 30, 45 and 90 Minutes After Using the Drug During Surgery
Method of measurement
Boezaart Scale

Secondary outcomes

empty

Intervention groups

1

Description
The First Intervention Group: The First Intervention Group: Desmopressin Spray, each 100 Ml of DESMEX Nasal Solution Contains 10 Mg of Desmopressin Acetate as an Active Ingredient and Benzalkonium Chloride as a Preservative. Each Puff Contains 10 Micrograms of Desmopressin Acetate. Each Nostril Receives 2 Puffs, Which Makes a Total of 40 Micrograms. This Spray Is Injected into the Patient's Nostrils Once 30 Minutes Before the Operation. the Manufacturer Is Sina Daru.
Category
Treatment - Drugs

2

Description
The Second Intervention Group: 0.25% Phenylephrine Drops, each 100 ml of NASOPHRIN Solution Contains 0.25 or 0.5 Grams of Phenylephrine Hydrochloride as an Active Ingredient and Benzalkonium Chloride as a Preservative. for Each Patient, 40 Drops of Phenylephrine Are Poured on 2 Tampons of 10 Cm and Then These Tampons Are Placed Inside the Nostrils of the Patient and After 10 Minutes the Tampons Are Removed and the Surgery Begins. the Manufacturer Is Sina Daru.
Category
Treatment - Drugs

3

Description
The Third Intervention Group: Tranexip Ampoule 500 Mg/5 m, Anti-Fibrinolysis, One Ampoule Is Broken for Each Patient and Two 10 Cm Tampons Are Dipped in It and One Tampon Is Placed in Each Nostril and After 10 Minutes We Take It Out. the Company Producing This Medicine Is Caspian Tamin.
Category
Treatment - Drugs

4

Description
Control group: 0.9% Sodium Chloride Solution in Volumes of 1000/500 Ml Is a Sterile, Pyrogen-Free, Preservative-Free and Isotonic Solution of Sodium Chloride in Water. Each Milliliter Contains 9 Mg of Sodium Chloride. We Soak 2 Tampons of 10 Cm and Put Them in the Nostrils of the Patients and After 10 Minutes We Take Them Out and Then the Surgery Begins. the Company Is an Iranian Manufacturer
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Ruhollah Abbasi
Street address
Shahid Beheshti Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۵۷۳۷۴۶۱
Phone
+98 81 3264 0030
Email
Besat@umsha.ac.ir
Web page address
https://besat.umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmide Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zamani
Position
Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
Rokni St., Magdiya Building 2
City
Hamedan
Province
Hamadan
Postal code
6516795679
Phone
+98 81 3821 2979
Fax
Email
LVLRE1378@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zamani
Position
Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
Rokni St., Magdiya Building 2
City
Hamedan
Province
Hamadan
Postal code
6516795679
Phone
+98 81 3821 2979
Fax
Email
LVLRE1378@GMAIL.COM

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Zamani
Position
Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technologist
Street address
Rokni St., Magdiya Building 2
City
Hamedan
Province
Hamadan
Postal code
6516795679
Phone
+98 81 3821 2979
Fax
Email
LVLRE1378@GMAIL.COM

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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