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IRCT20241211064021N14 IRCT 2026-01-04 Hamedan University of Medical Sciences Evaluation of the effect of adding dexmedetomidine to 0.5% hyperbaric bupivacaine on the quality of spinal anesthesia in lower limb surgeries Evaluation of the effect of adding dexmedetomidine to 0.5% hyperbaric bupivacaine on the quality of spinal anesthesia in lower limb surgeries 2026-01-05 anticipated 60 Recruiting https://irct.ir/trial/87532 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method will be used to implement random assignment. In this way, 60 consecutive numbers (from 1 to 60) will be written separately on paper and placed in a container.Each participant in the experiment is then asked to randomly select one of these 30 numbers from a container of numbers. Those who selected numbers 1 to 30 will be assigned to Group A ("Intervention Group 1"), and those who selected numbers 31 to 60 will be assigned to Group B ("Intervention Group 2"), Blinding description: In this study, blinding is performed in a double-blind manner, so that neither the patient nor the anesthesiologist responsible for the injection is aware of the group assignment. Drug solutions are prepared by someone other than the researchers and are identical in volume, color, and appearance. Group coding remains hidden until the end of statistical analysis. 2 Studying the effect of dexmedetomidine on improving the quality of spinal anesthesia with bupivacaine in lower limb surgeries. Intervention 1: In the intervention group, patients will receive dexmedetomidine. The drug is administered at a dose of 0.5 micrograms per kilogram of body weight as a slow intravenous infusion over 10 minutes before induction of general anesthesia. The purpose of administering this drug is to investigate its effects on reducing stress, the need for anesthetic drugs, and hemodynamic stabilization during surgery. During and after surgery, the patients' state of consciousness and vital signs will be recorded and monitored. No other sedative or anesthetic drugs will be changed at this stage, and all patients will be under the supervision of an anesthesiologist. Intervention 2: In the control group, instead of dexmedetomidine, patients receive an equal volume of normal saline (0.9%) as a slow intravenous infusion over the same period of time (10 minutes before induction of anesthesia). Patients in this group will also be placed under the same general anesthesia conditions and other anesthetics will be administered as in the intervention group. During and after the procedure, vital signs, level of consciousness, and need for anesthetics will be monitored and recorded to allow for a precise comparison between the two groups. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals When: After printing the article To whom: Researchers working in academic institutions Conditions: There is no prohibition to access the data Where to obtain: Ebadollah fadaei athar How to obtain: First, send an email to fadaeiebad@gmail.com and introduce yourself. Comments:
public Ebadollah Fadaei Athar
Hamadan
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 fadaeiebad@gmail.com Hamedan University of Medical Sciences scientific Ebadollah Fadaei Athar
Shahid Fahmedeh
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 fadaeiebad@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years No use of drugs affecting the central nervous system and anesthesia within the past 24 hours. Informed consent to participate in the study 25 years 65 years Both history of hypertension allergies to the drugs being studied M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs In the intervention group, patients will receive dexmedetomidine. The drug is administered at a dose of 0.5 micrograms per kilogram of body weight as a slow intravenous infusion over 10 minutes before induction of general anesthesia. The purpose of administering this drug is to investigate its effects on reducing stress, the need for anesthetic drugs, and hemodynamic stabilization during surgery. During and after surgery, the patients' state of consciousness and vital signs will be recorded and monitored. No other sedative or anesthetic drugs will be changed at this stage, and all patients will be under the supervision of an anesthesiologist In the control group, instead of dexmedetomidine, patients receive an equal volume of normal saline (0.9%) as a slow intravenous infusion over the same period of time (10 minutes before induction of anesthesia). Patients in this group will also be placed under the same general anesthesia conditions and other anesthetics will be administered as in the intervention group. During and after the procedure, vital signs, level of consciousness, and need for anesthetics will be monitored and recorded to allow for a precise comparison between the two groups. Severity of pain after surgery in the early hours. Timepoint: At intervals of 6, 12 and 24 hours after the completion of surgery. Method of measurement: Visual Pain Scale and Numerical Pain Scale. Duration of need for oral painkillers. Timepoint: Until discharge. Method of measurement: Record the number of days the patient required oral painkillers (other than usual home remedies) to control pain. Hamedan University of Medical Sciences Approved 2025-11-15 Research Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh St Hamadan Hamadan Iran (Islamic Republic of)