Determining and comparing the method of protecting corneal injuries in patients under general anesthesia with head and neck surgery
Design
Clinical trial with 3 groups, with parallel groups, double-blind, randomized, phase (There is no precedent) on 144 patients. Randomization will be using a table of random numbers generated by computer software
Settings and conduct
Location: Operating room of Bahonar and Shafa Hospital, Kerman, on the other hand, the patient is not aware of the allocation of treatment due to anesthesia, and in all cases the examiner (anaesthesiologist) is also unaware of the allocation of drugs, the interventions are performed by the nurse anesthetist.
Participants/Inclusion and exclusion criteria
Entry requirements: Age between 18 and 40 years
ASA ɪ and ɪɪ . candidate for head and neck surgery (except eyes)
candidate for general anesthesia
Exclusion criteria: patients with a history of previous eye damage
Eye surgery
Patients with an underlying disease that causes eye damage
Dissatisfaction of the patient and his companions
Intervention groups
Control group: eye protection by routine blindfolding with glue only
Intervention group 1: eye protection with tetracycline ointment (1% sterbel eye ointment of Najo factory) between the upper eyelid and lower eyelid plus glue
Intervention group 2: eye protection with tetracycline ointment (1% strebel eye ointment from Najo factory) which is completely filled under the upper eyelid, plus adhesive.
Main outcome variables
Redness of the eyes and conjunctiva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240216061022N1
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Jafar Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3311 2403
Email address
dr.jsalehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of corneal injury protection methods in patients under general anesthesia with head and neck surgery
Public title
Comparison of eye damage protection methods in patients under general anesthesia with head and neck surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 40 years
ASA ɪɪ and ɪ. candidate for head and neck surgery (except eyes)
candidate for general anesthesia
Exclusion criteria:
Patients with a history of previous eye damage
Eye surgery
Patients with an underlying disease that causes eye damage
Dissatisfaction of the patient and her companions
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a table of random numbers generated by computer software, so that each patient will be given a unique number, and then these numbers will be entered into the software and randomly assigned to one of the treatment groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, on the one hand, the patient is not aware of the allocation of treatment due to anesthesia, and in all cases, the examiner (anaesthetist) is also unaware of the allocation of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.KMU.AH.REC.1402.184
Health conditions studied
1
Description of health condition studied
Corneal injuries
ICD-10 code
S05.0
ICD-10 code description
Injury of conjunctiva and corneal abrasion without foreign body
Primary outcomes
1
Description
Redness of the eyes and conjunctiva
Timepoint
before the start of the operation, after the operation, in 2-6-12 hours and 24 hours after the operation
Method of measurement
Conjunctival Hyperemia Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: eye protection by routine blindfolding with glue only
Category
Prevention
2
Description
Intervention group: Eye protection by means of tetracycline ointment (1% strebel eye ointment from Najo factory) between the upper eyelid and the lower eyelid, plus glue.
Category
Prevention
3
Description
Intervention group: Eye protection by means of tetracycline ointment (1% strebel eye ointment of Najo factory), which is completely filled under the upper eyelid, plus glue.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Amir Reza Sadeghi Far
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarh@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Hossein Sadeghi Goghri
Street address
Iran, Kerman, Kausar Blvd., Shafa Medical Education Center
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3121 7281
Email
shafahospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Research and Technology Office, Samiya Crossroads (Tahmasababad), at the beginning of Ibn Sina Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
mahbobeh zare zadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Qarani Street, Shahid Bahonar Hospital
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahbubezarezade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Jafar Salehi
Position
Assistant Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kerman city ,shohada st. , No.208
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3311 2403
Fax
Email
dr.jsalehi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
mahbobeh zare zadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Qarani Street, Shahid Bahonar Hospital
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahbubezarezade@yahoo.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
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
At the end of the study, a part of the information comparing the methods of protecting the corneal damage in patients under general anesthesia with head and neck surgery after deidentifying the individuals will be shared with those interested in the field of healthcare.
When the data will become available and for how long
2 to 6 months after the statistical analysis of the data
To whom data/document is available
Researchers in the field of Medical
Under which criteria data/document could be used
In order to use the results and during the written request
What processes are involved for a request to access data/document
The purpose of accessing and using the data is to request an email to the author, a second email in case of no response as a reminder, confirmation of the requester's identity by the general respondent, sending the documentation file.