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IRCT20220513054842N1 IRCT 2022-10-30 Tehran University of Medical Sciences Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anesthesia for patients undergoing hip fracture surgery. Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anesthesiain patients undergoing hip fracture surgery. 2022-12-22 anticipated 125 Complete https://irct.ir/trial/66392 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The block randomization method will be used for the random allocation of patients,and the website www.sealedenvelope.com will be used.The website creates blocks randomly (keeping in mind that the number of study groups in each block is equal) and the number of generated blocks will be 35.Then he provides them as an Excel output to the random person. Only the anesthesiologist knows about the grouping of the patients and prepares the medicine needed for each group anonymously in the microset and provides it to the anesthesiologist (project manager).Enrollment in the study is determined based on the blocks made in order.For example, if the first quadruple block generated is norepinephrine/phenylephrine/phenylephrine/norepinephrine, the first and fourth patients are entered into the norepinephrine group and the second and third patients are entered into the phenylephrine group.The determination of the group was done by the anesthesiologist and the researchers will not know about this process and the structure of the blocks, Blinding description: The researched drugs are similar in color and are prepared anonymously with a special code by a nurse of anesthesia who is not involved in the research team.She records the syringe code, date, and patient file number in her notebook and keeps it with her until the end of the study. 2-3 Hypotension after spinal anesthesia. Intervention 1: Intervention group: After spinal anesthesia for hip surgery, intravenous infusion of norepinephrine 5 micrograms per minute is started. Intervention 2: Control group: After spinal anesthesia for hip surgery, intravenous infusion of phenylephrine 50 μg/min is started. Yes - There is a plan to make this available What will be shared: Main outcome data of the study When: 6 months after completing the study To whom: University researchers Conditions: Sharing scientific findings to increase the production of science Where to obtain: Email address of Dr. Nishaboury:mrnishaboury@tums.ac.ir How to obtain: The request should be made by email and the answer will be given within two months Comments:
public Mohammad Reza Neishaboury
Sinai Hospital,Imam Khomeini Street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8550 mrneishaboury@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Neishaboury
Sinai Hospital,Imam Khomeini Street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8550 mrneishaboury@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing hip fracture surgery who need spinal anesthesia according to the anesthesiologist's opinion Age older 50 years old Patient's consent to perform spinal anesthesia 50 years no limit Both The patient's inability to be in the right position or the presence of any contraindications for spinal anesthesia The need for general anesthesia according to the anesthesiologist Failure of spinal anesthesia I95.81 Postprocedural hypotension Prevention Prevention Intervention group: After spinal anesthesia for hip surgery, intravenous infusion of norepinephrine 5 micrograms per minute is started. Control group: After spinal anesthesia for hip surgery, intravenous infusion of phenylephrine 50 μg/min is started. Blood pressure. Timepoint: Every 3 minutes. Method of measurement: Digital pressure gauge. Heart Rate. Timepoint: Continuously. Method of measurement: ECG monitoring. Tehran University of Medical Sciences Approved 2022-08-02 Research Ethics Committee of Sina Hospital, Tehran University of Medical Sciences Sinai Hospital, Imam Khomeini Street Tehran Tehran Iran (Islamic Republic of)