The Effect of nasal spray of desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhino sinusitis
Comparison of the effects of nasal spray of desmopressin versus placebo on blood loss and the quality of the surgical field in endoscopic sinus surgery
Design
Randomized double-blind clinical trial
Settings and conduct
Patients were randomly allocated to two groups of desmopressin and placebo. The patients and analyst were blinded to the assignments, but the investigator and carers of the patients were informed . The setting was Rasoul Akram university hospital.
Participants/Inclusion and exclusion criteria
All patients must be 18–65 years old, and it is their first-time candidates for two-side FESS ;exclusion criteria are as follows: patients with a history of bleeding disorders or taking medications that may affect surgical hemostasis; secondary surgery; poorly controlled hypertension or cerebrovascular disease; a history of significant coronary artery disease or arrhythmias; a compromised renal or hepatic function; and pregnancy.
Intervention groups
Desmopressin
Main outcome variables
Intraoperative blood loss; quality of the surgical field during functional endoscopic sinus surgery; bleeding after the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101026005026N9
Registration date:2018-05-08, 1397/02/18
Registration timing:registered_while_recruiting
Last update:2018-05-08, 1397/02/18
Update count:0
Registration date
2018-05-08, 1397/02/18
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of nasal spray of desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhino sinusitis
Public title
The Effect of desmopressin administration on intraoperative blood loss of sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients must be 18–65 years old, who it is their first-time candidates for two-side FESS
Exclusion criteria:
Patients with a history of bleeding disorders or taking medications that may affect surgical homeostasis;
Poorly controlled hypertension or cerebrovascular disease;
A history of significant coronary artery disease or arrhythmia
Secondary surgery
Pregnancy
A compromised renal or hepatic function; and
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated to the Dessmopresin or Placebo groups.
Simple Randomization was performed, using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, outcome assessor and data analyser were blinded to the assignments.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical Sciences
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411174018
Health conditions studied
1
Description of health condition studied
Bleeding during endoscopic surgery of sinuses (FESS)
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Intraoperative blood loss
Timepoint
Every 15 minuets from the begining of anesthesia until maximum 90 minutes
Method of measurement
Final intraoperative blood loss was confirmed at the end of each procedure by accounting for loss of blood and irrigation fluid into the suction canister, and nasopharyngeal packing (measured weight of packing on the electronic scale)
2
Description
Quality of the surgical field during functional endoscopic sinus surgery
Timepoint
End of surgery
Method of measurement
A scoring scale adapted from Boezaart and van der merew
Secondary outcomes
1
Description
Bleeding after the surgery
Timepoint
Until 4 days after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
One puff Desmopressin nasal spray (10 μg) in either nostril before anesthesia
Category
Treatment - Drugs
2
Description
One puff nasal spray of normal saline in either nostril before anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Masood Mohseni
Street address
Rasoul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
Masood.Mohseni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
AliJavad Mosavi
Street address
Rasoul Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 5503
Email
mohseni@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
masood.mohseni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
masood.mohseni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arman Ghandi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
Dr.arman.ghandi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data regarding primary and secondary outcomes will be available
When the data will become available and for how long
Immediately after publication
To whom data/document is available
Only faculty members and academic institutions
Under which criteria data/document could be used
The result of further analysis may not be presented to public without permission
From where data/document is obtainable
masood.mohseni@gmail.com
What processes are involved for a request to access data/document
A reasonable request from an academic source will be responded within 10 working days