Effect of general anesthesia on postoperative cognitive function
Design
This study included 100 patients with ASA I or II who were candidate for general anesthesia at Besat Hospital, Hamadan, Iran.
Settings and conduct
The study population will include the patients with ASA I or II referring to Besat Hospital, Hamadan, Iran. They will be under general anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 60 years of age or higher; ASA I or II candidates for surgery under general anesthesia.
Exclusion criteria: History of alcohol and sedative as well as anticonvulsant drug consumption, and drug abuse; general anesthesia contraindications (cardiac failure, acute renal failure, acute liver failure, respiratory failure, bleeding disorders, myocardial infarction within the previous 6 weeks, stroke within the previous 6 months, progressive neurological disorders).
Intervention groups
The intervention group will receive general anesthesia according to standard methods. The type of medications may not be the same in all cases, but they will be administered based on standard anesthetic techniques.
Main outcome variables
The amount and severity of postoperative cognitive dysfunction will be evaluated and compared before, immediately after, and 10 months after general anesthesia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190429043414N2
Registration date:2019-07-12, 1398/04/21
Registration timing:prospective
Last update:2019-07-12, 1398/04/21
Update count:0
Registration date
2019-07-12, 1398/04/21
Registrant information
Name
Hossein Kimiaei Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3525 0182
Email address
kimiaeimd@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of general anesthesia on postoperative cognitive function: A clinical trial
Public title
Effect of general anesthesia on cognitive function
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
60 years of age or higher
ASA I or II candidates for surgery under general anesthesia
Exclusion criteria:
History of alcohol consumption
History of drug abuse consumption
History of sedative drug consumption
History of anticonvulsant drug consumption
General anesthesia contraindications
Cardiac failure
Acute renal failure
Acute liver failure
Respiratory failure
Bleeding disorders
Myocardial infarction within the previous 6 weeks
Stroke within the previous 6 months
Progressive neurological disorders
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Ayatollah Kashani Boulevard, Khaje Rashid Cross Roads
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.UMSHA.REC.1398.308
Health conditions studied
1
Description of health condition studied
Postoperative cognitive dysfunction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
Description
The amount and severity of postoperative cognitive dysfunction
Timepoint
Before, immediately after, and 10 months after spinal anesthesia.
Method of measurement
Wechsler Memory Scale-III (WMS-III) and the Mini Mental State Examination (MMSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive general anesthesia according to standard methods. The type of medications may not be the same in all cases, but they will be administered based on standard anesthetic techniques.
Hamadan University of Medical Sciences, Ayatollah Kashani Boulevard, Khaje Rashid Cross Roads
City
Hamadan
Province
Hamadan
Postal code
64517669644
Phone
+98 81 3820 1506
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Kimiaei Assadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hamadan University of Medical Sciences, Ayatollah Kashani Boulevard, Khaje Rashid Cross Roads
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3525 0182
Email
hkimiaeimd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Kimiaei Assadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hamadan University of Medical Sciences, Ayatollah Kashani Boulevard, Khaje Rashid Cross Roads
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3525 0182
Email
hkimiaeimd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Kimiaei Assadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hamadan University of Medical Sciences, Ayatollah Kashani Boulevard, Khaje Rashid Cross Roads
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3525 0182
Email
hkimiaeimd@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Hossein Kimiaei Assadiprovides the analysis code to the applicants via email: hkimiaeimd@yahoo.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.