The comparison of the effect of two general and Regional anesthesia in the incidence of delirium and early post-operative cognitive disorders post in senile patients with hip Fracture.
The aim of this study is the comparison of the effect of two general and regional anesthesia in the Incidence of delirium and early post-operative cognitive disorders after hip fracture surgery in senile patients.
Design
In a prospective and single blind, phase III clinical trial, ninety-eight senile patients candidated for operative repair of hip fractures, after selection in the study according to inclusion and exclusion criteria and getting informed consent, will be divided randomly (with block randomization method in blocks with 4 participant) into two parallel intervention (general anesthesia) and control (regional anesthesia) groups.
Settings and conduct
The study will be conducted in two university hospital. Before intervention, mental status and cognitive function of the patients as a basic value will be evaluated by MMSE and Wechsler standard tests, then patients of intervention group are going to operation under general anesthesia which is similar for all patients. In the control group, regional anesthesia (spinal or epidural) will be used during the surgery. In the following 5 days cognitive function of the all patients and the incident of the main outcomes would be evaluated with the use of above mentioned tests. The evaluating person in this phase is blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with hip fractures; Age over 50
Exclusion criteria:
History of cognitive and mental disorders; Age under 50; consumption of drugs effective on mental and cognitive function
Intervention groups
In the intervention group general anesthesia and in control group regional anesthesia will be used for anesthetic management of the patients during operation.
Main outcome variables
Delirium; Early post-operative cognitive disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121107011398N13
Registration date:2018-06-26, 1397/04/05
Registration timing:registered_while_recruiting
Last update:2018-06-26, 1397/04/05
Update count:0
Registration date
2018-06-26, 1397/04/05
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of two general and Regional anesthesia in the incidence of delirium and early post-operative cognitive disorders post in senile patients with hip Fracture.
Public title
The effect of anesthesia technique in the incidence of post-operative delirium and early post-operative cognitive disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for hip fracture fixation surgery
Age over 50 years
Have consent for participation in the study
ASA physical class I-III
Exclusion criteria:
Preoperative cognitive disorders
Alcohol and opiates abuse
ASA physical class over III
Not satisfied for participation in the study
Any contraindication for selection of general or regional anesthesia
History of any surgery and anesthesia in the past month
Electrolytic and acid-base drangments
History of psychotropic and benzodiazepines usage in the recent past week
History of cerebrovascular accident in the past year
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients Respectively, entering the study will be divided by using block randomization (4 person in each block) into two equals 49 cases group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who is responsible for pre & post operative cognitive tests evaluation is not aware from the grouping of patients.
The person who will doing statistical analysis is blind to grouping of the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Siences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-02-21, 1396/12/02
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511174001
Health conditions studied
1
Description of health condition studied
Postoperative delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Postoperative cognitive disorders
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Incidence of postoperative delirium
Timepoint
The day before and then daily after operation until 5th day
Method of measurement
Mini-mental state examination & Wechsler test
Secondary outcomes
1
Description
Early post operative cognitive disorders
Timepoint
The day before and then daily after operation until 5th day
Method of measurement
MMSE & Weschler tests
Intervention groups
1
Description
Intervention group: General anesthesia
Category
Treatment - Other
2
Description
Control group: Regional anesthesia (spinal & epidural)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Mohammadreza Ghodraty
Street address
Firoozgar hospital, Behafarin St, Karim Khan Av.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8894 6762
Email
h_firoozgar@yahoo.com
2
Recruitment center
Name of recruitment center
Hazrat-e-Rasool hospital
Full name of responsible person
Mohammadreza Ghodraty
Street address
Hazrt-e-Rasool hospital, Niayesh St, Sattar Khan Av.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2190
Email
mrghodrati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoud Naseripoor MD.
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Roghayeh Ehsani
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia department, Firoozgar hospital, Behafarin St, Karim Khan Av.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1600
Email
dr_kimia_ehsani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Ghodraty
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar hospital, Behafarin St, Karim Khan Av.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1600
Email
ghodrati.mr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Ghodraty
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology department, Firoozgar hospital, Behafarin St, Karim Khan Av.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1600
Email
ghodrati.mr@iums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After completion of the study and data collection, results will be imported to the main computerized data table. Results including demographic and background information of patients and analytical results will be published through both a thesis and as an article in specialized journals. Public access to the thesis and articles based on it will be assured.
When the data will become available and for how long
All documentation is saved on databases up to 6 years after study's completion. Access to and sharing of the data will be possible.
To whom data/document is available
University administration, editor-in-chiefs of journals, participants, all legally authorized persons.
Under which criteria data/document could be used
Use of study's protocol in further research to assure released data correctness, and to assure correct implementation of the protocol.
From where data/document is obtainable
Person responsible for scientific inquiries & corresponding author via email address:
Mohammadreza Ghodraty:
mrghodrati@yahoo.com
ghodrati.mr@iums.ac.ir
What processes are involved for a request to access data/document
Study's general data will be communicated by email in shortest delay. Confidential data which will identify patients is only granted if authorized by legal or administrative order