Protocol summary

Summary
The study is carried out as a one-center randomized clinical trial on 80 patients being at the age of 55 to 75 years old and candidate for cataract surgery in Velayat hospital of Qazvin province. Patients with abusers, Cold Intolerance and pharmaceutical mydriasis less than 5 mm are excluded. Patients randomly (using closed envelopes and choose A or B cards) are divided into two groups (intervention and control). Intervention: in the intervention group (cryo therapy), after the arriving of patients to the operating room, gel eye mask (cold in the refrigerator at 4 ± 2 ° C) for 5 minutes will be put on the eyes. Local anesthesia will be performed for all patients with similar method. In both groups, Tropicamide, Xylocaine and balanced salt solution (BSS) will be used, with the difference that in the intervention group all medications in a refrigerator (4±2 ° C temperature) and cooled. All patients will be without stitches. Vancomycin is an antibiotic used to prevent endophthalmitis. In the case of VPS> 4, the patient is treated with fentanyl 1 mg/kg during surgery. Systolic and diastolic blood pressure and heart rate will be measured at baseline, before of induction, 5, 10, 15, 30, 45 and 60 minutes after surgery, score of pain at 15, 30 and 60 after surgery, Postoperative complications and Patients satisfaction After entering the recovery are recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052734091N2
Registration date: 2017-07-08, 1396/04/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Matina Majdi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
m.majdi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cryo therapy on pain scores and contentment of patients in cataract surgery under topical anesthesia
Public title
Effect of cryo therapy on pain scores and contentment of patients in cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients 55 to 75 years old; candidate surgery of cataract; consent to participate up to the end study. Exclusion criteria: Need to inject propofol during surgery; opium addiction; psychotropic and analgesic drugs receivers; history of intraocular surgery; history of intraocular inflammatory diseases; other eye diseases; Pharmaceutical Mydriasis less than 5 mm; Cold Intolerance.
Age
From 55 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients randomly (using closed envelopes and choose A or B cards) are divided into two groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Comitte of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
3419759811
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.QUMS.REC.1396.12

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H26.9
ICD-10 code description
Cataract, unspecified

Primary outcomes

1

Description
postoperative pain
Timepoint
At 15, 30, 45 and 60 minutes after surgery
Method of measurement
Score of pain in verbal pain score (VPS)

2

Description
Systolic blood pressure
Timepoint
At baseline, before of induction, 5, 10, 15, 30, 45 and 60 minutes after surgery
Method of measurement
Monitoring devise

3

Description
Diastolic blood pressure
Timepoint
At baseline, before of induction, 5, 10, 15, 30, 45 and 60 minutes after surgery
Method of measurement
Monitoring devise

4

Description
Heart rate
Timepoint
At baseline, before of induction, 5, 10, 15, 30, 45 and 60 minutes after surgery
Method of measurement
Pulse Oxymetery

Secondary outcomes

1

Description
Postoperative complications(Headache, nausea and vomiting, shivering, respiratory depression)
Timepoint
After entering the recovery
Method of measurement
Questions from patient

2

Description
Patients satisfaction
Timepoint
After entering the recovery
Method of measurement
Questions from patient

Intervention groups

1

Description
In intervention group: after the arriving of patients to the operating room, gel eye mask (cold in the refrigerator at 4 ± 2 ° C) for 5 minutes will be put on the eyes and all medications in a refrigerator (4±2 ° C temperature) and cooled.
Category
Prevention

2

Description
In control group: Cold gel eye mask will not be used and Medications are not put in the refrigerator.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat educational and treatment center
Full name of responsible person
Dr. Matina Majdi
Street address
Velayat hospital, Taavon square, 22 Bahman Blvd, Minoodar, Qazvin.
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Matina Majdi
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Velayat hospital, Taavon square, 22 Bahman Blvd, Minoodar, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3376 0620
Fax
Email
dr.majdi1979@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr.Marzieh Beigom Khezri
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Medical school, Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mkhezri88@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Matina Majdi
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Velayat hospital, Taavon square, 22 Bahman Blvd, Minoodar, Qazvin.
City
Qazvin
Postal code
Phone
00
Fax
Email
dr.majdi1979@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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