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Comparison of the Effect of Propofol and Sevoflurane Anesthesia on Intraocular Pressure in Patients Undergoing Cataract Surgery.

Protocol summary

Study aim
Comparison of the Effect of Propofol and Sevoflurane Anesthesia on Intraocular Pressure in Patients Undergoing Cataract Surgery.
Design
Double blinded randomized clinical trial
Settings and conduct
After doing the blinding study so that the patient and assessor , who is a resident ophthalmologist and measures and records intraocular pressure, do not know the type of study groups.Patients are divided into two groups in the operating room of Khalili Hospital of Shiraz,in the first intervention group, anesthesia will be maintained with propofol 100 mg / kg /min . In the second intervention group, anesthesia will be maintained with a maintenance dose of sevoflurane (3.3% MAC) .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients candidate for cataract surgery ,Age 30-70 years, Class (ASA) I, II. Exclusion Criteria:allergies or adverse effects to any of the studied drugs, Blood pressure ,Congestive heart failure ,Difficult airway management or failure to pass the LMA ,Brain Tumor, IOP history ,Glaucoma ,Other eye diseases, Previous eye surgery.
Intervention groups
Intervention group:In the first intervention group, anesthesia will be maintained with propofol 100 mg / kg /min with oxygen and nitrous oxide of 0.5% and maintaining capnography between 30-35 mm Hg. In the second intervention group, anesthesia will be maintained with a maintenance dose of sevoflurane (3.3% MAC) and 0.5% oxygen and nitrous oxide and capnography 30-35 mm Hg.
Main outcome variables
Intraocular pressure, Blood pressure .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N97
Registration date: 2020-01-29, 1398/11/09
Registration timing: prospective

Last update: 2020-01-29, 1398/11/09
Update count: 0
Registration date
2020-01-29, 1398/11/09
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
2020-02-24, 1398/12/05
Expected recruitment end date
2020-04-24, 1399/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Propofol and Sevoflurane Anesthesia on Intraocular Pressure in Patients Undergoing Cataract Surgery.
Public title
Comparison the Effect of Propofol and Sevoflurane Anesthesia on Intraocular Pressure in Patients Undergoing Cataract Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for cataract surgery Age 30-70 years Class (ASA) I, II
Exclusion criteria:
Known allergies or adverse effects to any of the studied drugs Blood pressure Congestive heart failure Difficult airway management or failure to pass the LMA Brain Tumor IOP history Glaucoma Other eye diseases Previous eye surgery
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
At Randomomization.org, I receive two sets of 72 code from the table extracted from the site and share among the 144 study participants. (72 patients receiving will be assigned to the Sevoflurane group and the rest to the Propofol group) who will eventually be divided into the S and P groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and assessor , who is a resident ophthalmologist and measures and records intraocular pressure, do not know the type of study groups.
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
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.SUMS.MED.REC.1398.510

Health conditions studied

1

Description of health condition studied
Cataract Surgery
ICD-10 code
H25
ICD-10 code description
Age-related cataract

Primary outcomes

1

Description
Intraocular pressure
Timepoint
Baseline( before premedication), Before induction of anesthesia, 1min after induction of anesthesia, 1min after muscle relaxation, Immediately after LMA insertion, 5 min after LMA insertion, Immediately before extubation of the LMA, After extubation of the LMA
Method of measurement
Intraocular pressure monitor (Tonometer)

Secondary outcomes

1

Description
Blood pressure
Timepoint
From the beginning of the surgery every 5 minutes to 45 minutes (end of the operation)
Method of measurement
Blood pressure monitor

Intervention groups

1

Description
Intervention group:In the first intervention group, anesthesia will be maintained with propofol 100 mg / kg /min with oxygen and nitrous oxide of 0.5% and maintaining capnography between 30-35 mm Hg.
Category
Prevention

2

Description
Intervention group:In the second intervention group, anesthesia will be maintained with a maintenance dose of sevoflurane (3.3% MAC) and 0.5% oxygen and nitrous oxide and capnography 30-35 mm Hg.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Mohammad Amin Etezadi
Street address
Khalili Hospital, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3627 1671
Email
amin.etezadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
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
sacrc@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
Mohammad Amin Etezadi
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
amin.etezadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinabosadat Fatahi
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
parniafattahi@rocketmail.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
Its against our policies.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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