Evaluation on the Preventive Effects of Ketorolac and Nephaazolin- Anthrazoline Drops on Reducing Patient's Ocular Complications after Phacoamulsification Surgery under sedation
Evaluation of the Preventive Effect of Ketorolac and Nefazolin - Anthrazoline Drop on Reducing Patient's Ocular Complaints after Phacoamulsification Surgery under Sedation
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
This study will be performed on patients with cataract surgery in Isfahan and Feyz Hospital. Patients are divided into two groups. Patients in the first group are treated with ketorolac eye drops, and patients in the second group are treated with nefazolin antazoline eye drops, and the effect of these drops on reducing ocular complaints in patients is investigated. Patients, researchers, and data evaluators will be unaware of the group of patients.
Participants/Inclusion and exclusion criteria
Entry requirements:
1) Patients candidates for cataract surgery under local anesthesia and intravenous sedatives with class one or two American Anesthesia Associations
2) Age between 35 and 88 years
3) Written informed consent to participate in the study
No entry conditions:
1) Patients with glaucoma, uncontrolled hypertension, kidney disease, allergies to sedatives or studies
2) Proven mental-anxiety disorders
3) Inability to follow up patients up to 0.5 hours after recovery
4) History of allergy or allergic reaction to sedatives or studies
5) Any sensitivity to ketorolac
Intervention groups
Patients in the first group are treated with ketorolac eye drops, and patients in the second group are treated with nefazolin antazoline eye drops, and the effect of these drops on reducing ocular complaints in patients is investigated.
Main outcome variables
Pain; Nausea; Burning; Itching; Feeling a foreign object in the eye
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N1
Registration date:2020-06-18, 1399/03/29
Registration timing:prospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-19, 1399/05/29
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation on the Preventive Effects of Ketorolac and Nephaazolin- Anthrazoline Drops on Reducing Patient's Ocular Complications after Phacoamulsification Surgery under sedation
Public title
Preventive Effects of Ketorolac and Nephaazolin- Anthrazoline Drops on Reducing Patient's Ocular Complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the Patients undergoing Phacoamulsification Surgery under sedation
Exclusion criteria:
Patients with glaucoma, uncontrolled hypertension, kidney disease, allergies to sedatives or studied
Proven psycho-anxiety disorders
Inability to follow up patients up to 0.5 hours after recovery
History of allergy or allergic reaction to Sedatives or studies
Any sensitivity to ketorolac
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (for example, top or bottom) and the researcher's second default is to consider even numbers for group 1 and odd numbers for group 2.
The researcher begins to read the numbers in a predetermined manner and the patients are divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients will be assigned to two groups. Patients are not relieved of the drug content they receive because the appearance of all medications is the same. Clinical caregivers who give medications to patients also did not know what medication to give. After the course of treatment, to assess the effectiveness of the medication, the assessor does not know which patient has been treated with what medication and only fills in the information related to the questionnaires.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.MUI.MED.REC.1399.194
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Ocular Complaints
Timepoint
Every 15 minutes in the recovery unit and in the ward for half an hour until discharge from the hospital
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Receiver of ketorolac. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of ketorolac are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness
Category
Treatment - Drugs
2
Description
Intervention group2: Naphazoline-antazoline drug recipient. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of Naphazoline-antazolin are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz hospital
Full name of responsible person
Hamidreza Shetai
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.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
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
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
All potential data can be shared after people have not been identified
When the data will become available and for how long
From 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Free and on Web
Individuals can use the documents by visiting the research sites and the website of Isfahan University of Medical Sciences
From where data/document is obtainable
Free and on Web.
Individuals can use the documents by visiting the website of Isfahan University of Medical Sciences and submitting an application
What processes are involved for a request to access data/document