Comparison of Corneal methods protection during general anesthesia for functional endoscopic sinus surgery
Design
Randomized double-blind clinical trial
Settings and conduct
In patients of intervention group one, after implantation, the patient's eyelid endotracheal tube will be fixed with standard anti-allergy adhesive. In such a way that the patient's cornea is not exposed to air.
In patients in intervention group two, after endotracheal intubation, sterile gauze moistened with normal saline is placed on each eyelid and then the eye pad on the sterile gauze will be fixed with glue.
For patients in intervention group three, 0.5 cc of vitamin A ointment (Mahia Daroo, Iran) is used in each eye. In patients in intervention group four, 0.5 cc of hydrophilic gel (Bausch & Lomb Incorporated, Singapore) will be used in each eye to protect the cornea.
Participants/Inclusion and exclusion criteria
Patients undergoing sinus surgery by endoscopy ASA I-II.
History of any eye disease History of ocular trauma or any congenital or acquired abnormality Any type of eye surgery Pregnancy History of using any type of contact lens in the last week.
Intervention groups
In patients of intervention group one, after implantation, the patient's eyelid endotracheal tube will be fixed with standard anti-allergy adhesive. In such a way that the patient's cornea is not exposed to air.
In patients in intervention group two, after endotracheal intubation, sterile gauze moistened with normal saline is placed on each eyelid and then the eye pad on the sterile gauze will be fixed with glue.
For patients in intervention group three, 0.5 cc of vitamin A ointment (Mahia Daroo, Iran) is used in each eye. In patients in intervention group four, 0.5 cc of hydrophilic gel (Bausch & Lomb Incorporated, Singapore) will be used in each eye to protect the cornea.
Main outcome variables
Retinopathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N114
Registration date:2021-04-10, 1400/01/21
Registration timing:prospective
Last update:2021-04-10, 1400/01/21
Update count:0
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-18, 1400/01/29
Expected recruitment end date
2021-05-03, 1400/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Corneal methods protection during general anesthesia for functional endoscopic sinus surgery
Public title
Comparison of Corneal methods protection during general anesthesia for functional endoscopic sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing sinus surgery by endoscopy
ASA I-II
Exclusion criteria:
History of any eye disease
History of ocular trauma or any congenital or acquired abnormality
Any type of eye surgery
Pregnancy
History of using any type of contact lens in the last week
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
72 patients in the 4 study groups and 18 blocks of four permutations, enter a random list of sealedenvelpe.com which is extracted from the site.
Researchers, including ophthalmologists and statisticians, are not informed about the patient group.
After collecting the forms, according to the randomized list, each patient's group is registered on the form.
Blinding (investigator's opinion)
Single blinded
Blinding description
Ophthalmologist at the time of corneal examination after surgery and statisticians do not know how to assign study groups, after collecting the forms, according to the randomized list, each patient's group is registered on the form.
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
Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.SUMS.MED.REC.1398.654
Health conditions studied
1
Description of health condition studied
functional endoscopic sinus surgery
ICD-10 code
J01
ICD-10 code description
Acute sinusitis
Primary outcomes
1
Description
Retinopathy
Timepoint
After transfer to the patient to the recovery room
Method of measurement
fluorescein eye stain test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients of intervention group one, after implantation, the patient's eyelid endotracheal tube will be fixed with standard anti-allergy adhesive. In such a way that the patient's cornea is not exposed to air.
Category
Prevention
2
Description
Intervention group: In patients in intervention group two, after endotracheal intubation, sterile gauze moistened with normal saline is placed on each eyelid and then the eye pad on the sterile gauze will be fixed with glue.
Category
Prevention
3
Description
Intervention group: For patients in intervention group three, 0.5 cc of vitamin A ointment (Mahia Daroo, Iran) is used in each eye.
Category
Prevention
4
Description
Intervention group: In patients in intervention group four, 0.5 cc of hydrophilic gel (Bausch & Lomb Incorporated, Singapore) will be used in each eye to protect the cornea.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Laleh Dehghan Pisheh
Street address
Khalili Hospital، Khalili Street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
khalili@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrd@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
Seyed Shahin Hakimi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yaoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Laleh Dehghan Pisheh
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
lalehdehghan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.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