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IRCT20260124068652N1 IRCT 2026-06-17 Arak University of Medical Sciences Effect of sulfate magnesium and midazolam in reducimg pain in pation who candidates for tul English Title: Comparison of the effect of adding magnesium sulfate and midazolam to 0.5% bupivacaine spinally in reducing postoperative pain in patients who are candidates for ureteric stone surgery 2026-06-02 anticipated 60 Complete https://irct.ir/trial/88874 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated into two groups using block randomization with block sizes of 2 and 4. The random sequence will be generated by an independent individual who is not involved in participant recruitment or assessment, using the online program available on the Sealed Envelope website. After confirming eligibility criteria and obtaining informed consent, each participant will receive a unique identification number in the order of enrollment and will be assigned to one of the two groups according to the pre‑generated random sequence. Allocation concealment will be ensured using opaque, sealed, and sequentially numbered envelopes containing each participant’s group assignment, Blinding description: "To ensure a double-blind design, data will be measured and recorded by an intern who is unaware of the group allocations. Medication preparation for each group will be performed by a nurse anesthetist, while the spinal anesthesia will be administered by an anesthesiologist. Consequently, due to the lack of knowledge regarding group sequences and interventions among both the patients and the outcome assessors, the study will be double-blinded.". 3 postoperative pain in patients who are candidates for ureteric stone surgery. Intervention 1: Midazolam Group (M): Patients will receive 2 mg of preservative-free midazolam ( caspian pharmaceutical co , Rasht iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia. Intervention 2: Intervention group: Magnesium Sulfate Group (S): Patients will receive 100 mg of magnesium sulfate ( 10% solution , pasteur institue of iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia. 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 Shadi rostamikia
Shahid shirudi street , valiasr square , valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 905 693 4020 ra.jafari009@yahoo.com Arak University of Medical Sciences scientific Shadi Rostamikia
Khoram street ,
Arak Iran (Islamic Republic of) 3813857673 +98 905 693 4020 emadbulters1976@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 18 to 60 years old Asa class 1 and 2 Patients who candidates for tul 18 years 60 years Both Existential body mass index more than 30 ssensitivness to useful drugs cardiovascular problems coagolopathy arrhythmia Treatment - Drugs Treatment - Drugs Midazolam Group (M): Patients will receive 2 mg of preservative-free midazolam ( caspian pharmaceutical co , Rasht iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia. Intervention group: Magnesium Sulfate Group (S): Patients will receive 100 mg of magnesium sulfate ( 10% solution , pasteur institue of iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia. Postoperative pain. Timepoint: 1,2,4,612 hours after operation. Method of measurement: Visual analogue scale. Arak University of Medical Sciences Approved 2025-12-21 Ethics committee of arak medical university Sardasht basij square Arak Markazi Iran (Islamic Republic of)