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IRCT20121107011398N13 IRCT 2018-06-26 Iran University of Medical Sciences The effect of anesthesia technique in the incidence of post-operative delirium and early post-operative cognitive disorders 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. 2018-04-09 anticipated 98 Complete https://irct.ir/trial/11666 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A Condition 1: Postoperative delirium. Condition 2: Postoperative cognitive disorders. Intervention 1: Intervention group: General anesthesia. Intervention 2: Control group: Regional anesthesia (spinal & epidural). Yes - There is a plan to make this available What will be shared: 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: 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: University administration, editor-in-chiefs of journals, participants, all legally authorized persons. Conditions: Use of study's protocol in further research to assure released data correctness, and to assure correct implementation of the protocol. Where to obtain: Person responsible for scientific inquiries & corresponding author via email address: Mohammadreza Ghodraty: mrghodrati@yahoo.com ghodrati.mr@iums.ac.ir How to obtain: 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 Comments:
public Roghayeh Ehsani
Anesthesia department, Firoozgar hospital, Behafarin St, Karim Khan Av.
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1600 dr_kimia_ehsani@yahoo.com Iran University of Medical Sciences scientific Mohammadreza Ghodraty
Firoozgar hospital, Behafarin St, Karim Khan Av.
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1600 ghodrati.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients candidate for hip fracture fixation surgery Age over 50 years Have consent for participation in the study ASA physical class I-III 50 years no limit Both 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 F05 F06.7 Delirium due to known physiological condition Mild cognitive disorder Treatment - Other Treatment - Other Intervention group: General anesthesia Control group: Regional anesthesia (spinal & epidural) 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. Early post operative cognitive disorders. Timepoint: The day before and then daily after operation until 5th day. Method of measurement: MMSE & Weschler tests. Iran University of Medical Sciences Approved 2018-02-21 Ethics committee of Iran University of Medical Siences Iran University of Medical Sciences, Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)