Effect of local desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis
Finding cost effective method to decrease bleeding and improve the visual field of the surgery in the patients who candidate for functional endoscopic sinus surgery
Design
Triple blinded, clinical trial with 88 patients
Settings and conduct
Patients undergoing endoscopic sinus surgery who have been referred to otolaryngology clinic ofHamadan Besat hospital, since the adoption of the plan for one year, will be included in the study if they are eligible for entry and consents. Blind mode: Due to the type of intervention and coding, patients, researchers and analyst, do not know the contents of the used spray.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients suffering from chronic rhinosinusitis who candidates for endoscopic sinus surgery
Exclusion criteria: Suffering from sinunasal tumors
Intervention groups
All patients used a nasal spray with an unspecified substance, thirty minutes before the start of the surgery, in each side of the nose; the contents of the nasal sprays included Desmopressin in the case group (10 micrograms in each puff, 20 micrograms in total) and normal Saline in control group.
Main outcome variables
Amount of blood volume; visual field of surgery; blood pressure changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130713013976N5
Registration date:2018-04-24, 1397/02/04
Registration timing:retrospective
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Javaneh Jahanshahi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
j.jahanshahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical science,researching center
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-08-01, 1396/05/10
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
empty
Scientific title
Effect of local desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis
Public title
Effect of local desmopressin administration on intraoperative blood loss and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from chronic rhinosinusitis with or without polyposis
Between 18 to 60 years old
Normal coagulative tests and platelet count
Exclusion criteria:
Suffering from coagulative disorders like Hemophilia
Suffering from sinunasal tumors
History of thromboembolic accident
Suffering from acute or chronic renal failure
Receiving Heparin in 48 hour before surgery
Receiving Aspirin in 3 days before surgery
Allergy to Desmopressin
Liver scirrhosis
Systemic diseases like hypertension, diabet mellitus, heart failure
Pregnancy
Cardiac stent
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Actual sample size reached:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Six-block randomization is used for this purpose. Six piece of paper prepared while in 3 of them letter A and in 3 others letter B was written. After mixing the papers all of them were put in the drawer desk. For any volunteer patient one of the papers will be removed randomly and by the letters they were divide in intervention or control groups. After removal of all the papers , they were charged again. This process is continued up to achieve to samples volume.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Before starting the research and after accepting consent ,is explained to patients that they would entered in each groups of receiving topical desmopressin nasal spray(intervention) or normal saline(control group) .Because of the bottles`s same look and their filling and coding by pharmacist who participate in the research, neither researcher nor the patients have idea about contents of the bottles and their codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
Ethics Committee of Hamadan University of Medical Science, Khaje Rashid Blv., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
1234567890
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.UMSHA.REC.1396.11
Health conditions studied
1
Description of health condition studied
Chronic rhinosinusitis
ICD-10 code
J32.4
ICD-10 code description
Chronic pansinusitis
Primary outcomes
1
Description
visual field of surgery
Timepoint
15,30,60,90 minutes after starting surgery
Method of measurement
Boezaart Grading
2
Description
bleeding volume
Timepoint
15,30,60,90 minutes after starting surgery
Method of measurement
blood volume in suction s bottle
Secondary outcomes
1
Description
mean arterial pressure
Timepoint
before and in points of 15,30,60 and 90 min after surgery
Method of measurement
blood pressure monitoring
2
Description
surgery duration
Timepoint
time of starting upto end of the surgery
Method of measurement
recording duration of surgery
3
Description
serum sodiume level
Timepoint
before and after the surgery
Method of measurement
serum sodiume level test
Intervention groups
1
Description
Intervention group: Single puff of Desmopressin nasal spray, 30 minutes before starting the surgery in each side of nasal cavity (10 micro gram in each side). This drug complete name is Desmopressin Acetate and this study has used a product of SINA-Darou factory with concentration of 100 mcg in 1 ml (each puff contains 10 mcg as noted).
Category
Treatment - Drugs
2
Description
Control group: Single puff of Saline 0.65% nasal spray , 30 minutes before starting the surgery in each side of nasal cavity.This study has used a product of SINA-Darou factory with concentration of 65 gr in 100 cc.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT department of BESAT hospital
Full name of responsible person
Dr Javaneh Jahanshahi , Dr Elham Tayebi
Street address
Besat hospital ENT department,Shahid Beheshti Blvd,Hamadan
City
Hamadan
Province
Hamadan
Postal code
32651515
Phone
+98 81 3264 0030
Fax
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Solgi Ghasem
Street address
University of Medical science,Ayatollah Kashani Blvd,Hamadan,Iran.
City
Hamadan
Province
Hamadan
Postal code
1234567890
Phone
+98 81 3838 0462
Email
ICT@umsha.ac.ir
Web page address
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
Elham Tayebi
Position
ENT resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
BESAT Hospital,Shahid Beheshti Blvd,Hamadan
City
Hamadan
Province
Hamadan
Postal code
1234567890
Phone
+98 81 3264 0020
Fax
Email
e_tayyebi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Javaneh Jahanshahi
Position
faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
BESAT hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
1234567890
Phone
+98 81 3264 0020
Fax
Email
J.JAHANSHAHI@UMSHA.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elham Tayebi
Position
ENT resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahid Beheshti Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
123456780
Phone
+98 81 3264 0030
Fax
Email
e_tayyebi@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of personal information and data could be shared
When the data will become available and for how long
Access starts from 6 months after results publishing