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IRCT20220410054482N1 IRCT 2022-06-01 Hamedan University of Medical Sciences Comparing the effect of Trendelenburg with Supine position on the quality of the surgical field, hemodynamic, cerebral oximetry and cognitive function of patients under open radical prostatectomy procedure Comparing the effect of Trendelenburg with Supine position on the quality of the surgical field, hemodynamic, cerebral oximetry and cognitive function of patients under open radical prostatectomy procedure 2022-04-09 anticipated 60 Complete https://irct.ir/trial/63026 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects (60 patients) will allocate to two equal groups (each group 30 patients) of intervention (A) and control (B) using blocking randomization method. Randomization tool is the random allocation software version 1. The software and instructions for using it are available at https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html. After installing the program, to generate a random sequence, the number of groups (2 groups), the name of each group (A= 1, B= 2), the sample size (60 patients) and the block size (number 4) will be entered into the software. Accordingly, 15 blocks of 4, including two groups A and B, will be randomly designed by the software. To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed. N/A Open radical prostatectomy. Intervention 1: Intervention group: Subjects will be placed in 15° Trendelenburg by tilting the operating table before starting surgery. Intervention 2: Control group: Subjects will be stay in sleeping position on the back during surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Hanieh Bahadori
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 936 351 9185 haniyehbahadori75@gmail.com Hamedan University of Medical Sciences scientific Hanieh Bahadori
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 936 351 9185 haniyehbahadori75@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Tendency to participate in the study Indication for open radical prostatectomy surgery Having ASA Physical Status I or II no limit no limit Male History of ischemic injuries or cerebrovascular hemorrhage History of degenerative neurological diseases (such as Alzheimer and Parkinson) and any intracranial pathology N40 Enlarged prostate Prevention Prevention Intervention group: Subjects will be placed in 15° Trendelenburg by tilting the operating table before starting surgery. Control group: Subjects will be stay in sleeping position on the back during surgery. Quality of the surgical field. Timepoint: After surgery. Method of measurement: Criteria for evaluating the quality of the surgical field. Hemodynamic. Timepoint: Before anesthesia, after induction of anesthesia, after positioning, every 10 minutes after the start of surgery and at the end of surgery. Method of measurement: Heart rate and non-invasive blood pressure monitoring device. Cerebral oximetry. Timepoint: Before anesthesia, after induction of anesthesia, after positioning, every 10 minutes after the start of surgery and at the end of surgery. Method of measurement: Near-Infrared Spectroscopy device. Cognitive function. Timepoint: Before and 6 hours after surgery. Method of measurement: Mini-mental state examination. Hamedan University of Medical Sciences Approved 2022-04-09 Research Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)