Evaluation of the hemostatic effect of desmopressin nasal spray in rhinoplasty
Design
This study will be a double-blind randomized clinical trial with parallel groups on 88 patients who will be undergoing rhinoplasty. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Mir Hosseini Hospital will be included in the study. Patients participating in the study, the researcher, and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Mir Hosseini hospital who will undergo rhinoplasty with consent to participate in the study. Exclusion criteria: patients with hemodynamic instability or coagulation disorders.
Intervention groups
Intervention group: Patients one hour before surgery will receive Nasal spray desmopressin, two puffs on each side of the nose. A total of 40 micrograms of desmopressin is given to the patient. Control group: Patients will receive two puffs of normal saline spray.
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210424051060N1
Registration date:2021-05-18, 1400/02/28
Registration timing:registered_while_recruiting
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Zohre Nazarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 0005
Email address
nazarpourz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-04, 1400/02/14
Expected recruitment end date
2021-05-31, 1400/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemostatic effect of desmopressin nasal spray in rhinoplasty
Public title
Evaluation of the hemostatic effect of desmopressin nasal spray in rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Hemoglobin above 10
Patients without coagulation disorders
Exclusion criteria:
Coagulant disorder
A condition associated with clot such as CVA, thrombosis
Drug sensitivity to desmopressin
Hypertension
Taking drugs that affect coagulation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups of intervention and control by tossing a coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used, so that the participant in the study, the researcher and the data collector do not know which patients received desmopressin nasal spray and which patients received normal saline spray.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.SUMS.MED.REC.1400.031
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding
Timepoint
In the 30th and 60th minutes after the start of surgery
Method of measurement
According to Beozaart criteria
Secondary outcomes
1
Description
Surgeon satisfaction
Timepoint
At the end of surgery
Method of measurement
According to the Likert scale
2
Description
Length of surgery
Timepoint
End of surgery
Method of measurement
Surgery time based on minutes
Intervention groups
1
Description
Intervention group: One hour before the start of nasal spray surgery, desmopressin will be given, two puffs on each side of the nose, giving the patient a total of 40 micrograms of desmopressin acetate.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive two puffs of normal saline spray.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mir Hosseini Hospital
Full name of responsible person
Zohreh Nazarpour Sarvak
Street address
Shiraz - Atlasi Square - Hijrat Boulevard - facing Abiramaz Street - Dr. Mir Hosseini Specialized and Sub-Specialized Hospital
City
Shiraz
Province
Fars
Postal code
۰۷۱۳۲۲۸۴۴۳۴
Phone
+98 71 3228 4434
Email
zohreh_nazarpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3234 9333
Email
med-thesis@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Nazarpour Sarvak
Position
ENT resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸۹۸۷۱۳۲۳
Phone
+98 915 709 0986
Email
Zohrenazarpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Nazarpour Sarvak
Position
ENT resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
zohreh_nazarpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Nazarpour Sarvak
Position
ENT resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shiraz, Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
zohreh_nazarpour@yahoo.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