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IRCT20240929063203N3 IRCT 2025-11-18 Bandare-abbas University of Medical Sciences Comparison of Two Different Doses of Remifentanil on Bleeding and Hemodynamics in Femur Surgery Comparison of the Effects of Two Different Doses of Remifentanil Infusion on Intraoperative Blood Loss and Hemodynamic Parameters in Patients Undergoing Femur Surgery 2025-11-22 anticipated 60 Complete https://irct.ir/trial/87430 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, simple block randomization with individual randomization units will be used. Patients aged 18 to 70 years with ASA class I and II who are candidates for femur surgery under general anesthesia will be placed in blocks of 4 and 6 individuals and assigned in a 1:1 ratio to two groups: low-dose (0.25 mcg/kg/min) and high-dose (0.5 mcg/kg/min) remifentanil. Random Allocation Software will be used to generate the random sequence, with sealed opaque envelopes as a backup method. The seed number will be extracted from the system time at execution and recorded for reproducibility. Allocation concealment will be ensured through a central system that does not reveal allocation until complete patient information is registered, unique coding for each patient, separation of research team responsibilities (separation of enrollment personnel from allocation personnel), emergency envelopes for urgent cases, restricted access control to the randomization sequence, and complete process documentation to minimize selection bias, Blinding description: This is a double-blind clinical trial in which patients, surgeons, surgical team, and outcome assessors will be unaware of the remifentanil dose administered (0.25 or 0.5 μg/kg/min) and the patient's group allocation. Drug preparation and administration will be performed by an anesthesiologist who is not involved in outcome assessment, and syringes containing remifentanil will be prepared with coded labels (A or B) without indicating the actual dose. Allocation codes will be kept in sealed envelopes and will not be opened until the end of the study and completion of data analysis, except in emergency situations. Data collection will be performed by a nurse or research assistant who is blinded to patient grouping, and only the anesthesiologist responsible for drug preparation and the person responsible for randomization (who are not involved in enrollment and outcome assessment) will be aware of the allocation. 3 Surgery. Intervention 1: Intervention group 1: Patients undergoing elective femur surgery under general anesthesia will receive intravenous remifentanil infusion at a dose of 0.25 micrograms per kilogram per minute. The infusion will start after anesthesia induction and continue until the end of surgery. Anesthesia induction protocol includes: Midazolam 0.1 mg/kg, Fentanyl 2 micrograms/kg, Propofol 2 mg/kg, and Atracurium 0.5 mg/kg. All patients will also receive Morphine Sulfate 0.1 mg/kg intraoperatively for analgesia. Drug name: Remifentanil (as Ultiva or equivalent), Route of administration: Continuous intravenous infusion, Dose: 0.25 µg/kg/min, Duration: From anesthesia induction until end of surgery. Intervention 2: Intervention group 2: Patients undergoing elective femur surgery under general anesthesia will receive intravenous remifentanil infusion at a dose of 0.5 micrograms per kilogram per minute. The infusion will start after anesthesia induction and continue until the end of surgery. Anesthesia induction protocol includes: Midazolam 0.1 mg/kg, Fentanyl 2 micrograms/kg, Propofol 2 mg/kg, and Atracurium 0.5 mg/kg. All patients will also receive Morphine Sulfate 0.1 mg/kg intraoperatively for analgesia. Drug name: Remifentanil (as Ultiva or equivalent), Route of administration: Continuous intravenous infusion, Dose: 0.5 µg/kg/min, Duration: From anesthesia induction until end of surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Still undecided - no release schedule yet.
public Mehrdad Malekshoar
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 1551979199 +98 76 3334 5009 mdmalekshoar@yahoo.com‏ Bandare-abbas University of Medical Sciences scientific Mehrdad Malekshoar
Next to Recovery, 5-story building, first floor, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 1551979199 +98 76 3334 5009 mdmalekshoar@yahoo.com‏ Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18 to 70 years Candidates for femur surgery Undergoing general anesthesia No use of opioid analgesics before surgery No history of allergy or hypersensitivity to remifentanil or similar drugsRetry 18 years 70 years Both Diagnosis of serious diseases or medical conditions that may affect the study outcomes (such as severe cardiovascular disorders or bradycardia) Allergy or severe hypersensitivity reaction to the medications used in the study. Lack of informed consent or withdrawal of the patient from the study at any stage of the research. If patients require additional morphine during the procedure. Z47.82 Encounter for orthopedic aftercare following scoliosis surgery Treatment - Drugs Treatment - Drugs Intervention group 1: Patients undergoing elective femur surgery under general anesthesia will receive intravenous remifentanil infusion at a dose of 0.25 micrograms per kilogram per minute. The infusion will start after anesthesia induction and continue until the end of surgery. Anesthesia induction protocol includes: Midazolam 0.1 mg/kg, Fentanyl 2 micrograms/kg, Propofol 2 mg/kg, and Atracurium 0.5 mg/kg. All patients will also receive Morphine Sulfate 0.1 mg/kg intraoperatively for analgesia. Drug name: Remifentanil (as Ultiva or equivalent), Route of administration: Continuous intravenous infusion, Dose: 0.25 µg/kg/min, Duration: From anesthesia induction until end of surgery. Intervention group 2: Patients undergoing elective femur surgery under general anesthesia will receive intravenous remifentanil infusion at a dose of 0.5 micrograms per kilogram per minute. The infusion will start after anesthesia induction and continue until the end of surgery. Anesthesia induction protocol includes: Midazolam 0.1 mg/kg, Fentanyl 2 micrograms/kg, Propofol 2 mg/kg, and Atracurium 0.5 mg/kg. All patients will also receive Morphine Sulfate 0.1 mg/kg intraoperatively for analgesia. Drug name: Remifentanil (as Ultiva or equivalent), Route of administration: Continuous intravenous infusion, Dose: 0.5 µg/kg/min, Duration: From anesthesia induction until end of surgery. Volume of blood loss during femur surgery measured in milliliters. Timepoint: Measured continuously during the surgery from the start of the surgical incision until wound closure. Method of measurement: Measurement of blood volume collected in suction containers and blood-soaked surgical gauzes during surgery. Systolic blood pressure measured in millimeters of mercury during femur surgery. Timepoint: Measured at baseline (before anesthesia induction) and at 15-minute intervals during surgery. Method of measurement: Non-invasive blood pressure monitoring device (automated sphygmomanometer). Diastolic blood pressure measured in millimeters of mercury during femur surgery. Timepoint: Measured at baseline (before anesthesia induction) and at 15-minute intervals during surgery. Method of measurement: Non-invasive blood pressure monitoring device (automated sphygmomanometer). Mean arterial pressure measured in millimeters of mercury during femur surgery. Timepoint: Measured at baseline (before anesthesia induction) and at 15-minute intervals during surgery. Method of measurement: Calculated automatically by non-invasive blood pressure monitoring device using the formula: MAP = DBP + 1/3(SBP - DBP). Heart rate measured in beats per minute during femur surgery. Timepoint: Measured at baseline (before anesthesia induction) and at 15-minute intervals during surgery. Method of measurement: Electrocardiogram (ECG) monitoring device and pulse oximeter. Hormozgan University of Medical Sciences Approved 2025-08-19 Research Ethics Committees of Hormozgan University of Medical Sciences Shahid Chamran Boulevard, University of Medical Sciences and Health Services, Bandar Abbas. Bandar Abbas Hormozgan Iran (Islamic Republic of)