A comparative study of two different levels of end exhaustion carbon dioxide pressure with cognitive status of patients after cataract surgery in patients referred to Faiz Hospital in 2017-18
Comparison of two different level of end Exhaustion of carbon dioxide pressure on cognitive status in patients under cataract surgery
Design
This study is a double-blind randomized clinical trial study with parallel groups. 240 patients undergoing cataract surgery will be divided into two groups of 120 with using Random Allocation Software. The effect of two levels of End-tidal carbon dioxide on postoperative cognitive impairment is investigated.
Settings and conduct
This study was carried out in Feyz hospital in Isfahan during 219-20. 240 patients undergoing cataract surgery were divided into two groups of 120 each, in the first group the End-tidal carbon dioxide pressure was maintained at 35-40 mmHg and in the second group 40-45 mmHg and the incidence of postoperative cognitive impairment will be determined in to groups. The study was double-blind and the patient and collector were unaware of the patients' allocation to the groups.
Participants/Inclusion and exclusion criteria
In this study, 240 patients undergoing cataract surgery general anesthesia with ASA 1,2, above 65 years old , who agreed to participate in the study were enrolled. Patients with a history of allergy to anesthetics drugs or a history of moderate to severe psychiatric disorder are not entered in to the study
Intervention groups
Group Intervention 1: End-tidal carbon dioxide level between 35-40 mmHg
Group Intervention 2: End-tidal carbon dioxide level between 40-45 mmHg
Main outcome variables
Cognitive ِDisorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N36
Registration date:2019-09-15, 1398/06/24
Registration timing:prospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of two different levels of end exhaustion carbon dioxide pressure with cognitive status of patients after cataract surgery in patients referred to Faiz Hospital in 2017-18
Public title
The effect of two levels of end exhaustion carbon dioxide pressure on the cognitive status of patients undergoing cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Candidate for cataract surgery ander general anesthesia
age above 65 years
American Society Anesthesiologist:1,2
Exclusion criteria:
History of allergy to anesthesial drugs
History of moderate or severe psychological disorders
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
240 patients under cataract surgery were selected and randomly allocated in tot two groups by Random Allocation Software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the level of the end exhaustion carbon dioxide pressure. Also, the level of CO2 at the end of the expiration of patients will be apply by the researcher and the outcome of the study is determined and recorded by another physician who is unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
ir.mui.rec.1396.3.612
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H40.10
ICD-10 code description
Unspecified open-angle glaucoma
Primary outcomes
1
Description
Cognitive Disorder
Timepoint
Until 24 hours after surgery
Method of measurement
Mini- Mental Status Examination check list
Secondary outcomes
1
Description
Hemodynamic Disorder
Timepoint
Every 15 minutes during operation and recovery
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group1: Level of End-Tidal Carbon Dioxide is set between 35-40 mmHg
Category
Treatment - Surgery
2
Description
Intervention group2: Level of End-Tidal Carbon Dioxide is set between 40-45 mmHg
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Kobra Nasrollahi
Street address
Modarres Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
Nasrollahi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayesh Haghjoo
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
haghjoo@med.mui.ac.ir
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
Najmeh Askarianfard
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Soffeh Street
City
Iasfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
Na.askarianfard93@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kourosh Naghibi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
naghibi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174643461
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.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
Information belongs to government agency
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
Yes - There is 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
Title and more details about the data/document
Because the information belongs to a government agency, it cannot be shared..
When the data will become available and for how long
Any time
To whom data/document is available
Any person
Under which criteria data/document could be used
Under any circumstances
From where data/document is obtainable
Any person, any time
What processes are involved for a request to access data/document