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IRCT20250809066791N1 IRCT 2025-11-04 Qazvin University of Medical Sciences Comparison of hypobaric unilateral spinal anesthesia versus general anesthesia on heart rate, blood pressure change and mortality in hip fracture surgery Comparison of hypobaric unilateral spinal anesthesia versus general anesthesia on heart rate, blood pressure change and mortality in hip fracture surgery 2025-11-22 anticipated 60 Complete https://irct.ir/trial/85474 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Hip fracture surgery. Intervention 1: Intervention group: Unilateral Spinal Anesthesia with Ropivacaine and Sufentanil: In this group, patients undergo Unilateral Spinal Anesthesia (ULSA). After injecting 500 cc of normal saline, the patient is placed in a sitting position. The hypobaric anesthetic solution is prepared with the following ingredients: 0.5% Ropivacaine, 2 ml (10 mg) of Sufentanil, 1 ml (5 μg) of distilled water, 1 ml. A total of 4 cc of the prepared solution is injected into the subarachnoid space L4–L5 (or a higher or lower space) with a 23 G needle. After injection, the patient is placed in a lateral position on the non-involved side (fracture area upwards) for 5 minutes to limit the spread of the drug to that side. In case of mild pain during the procedure (NRS <4), an opioid infusion is used. If the patient's pain is not controlled, general anesthesia is performed and the patient is excluded from the study. Monitoring of mean arterial blood pressure (MAP) and heart rate is performed every 3 minutes, as in the control group, and in case of hypotension, treatment with ephedrine and, if necessary, norepinephrine is performed. Intervention 2: Control group: General anesthesia with isoflurane and standard induction drugs: In this group, patients are put under general anesthesia. After injecting 500 cc of normal saline and premedication with midazolam at a dose of 0.02 mg/kg, sufentanil at a dose of 0.2 μg/kg, propofol at a dose of 1 mg/kg, and atracurium at a dose of 0.5 mg/kg, anesthesia is used to induce anesthesia. After ensuring proper airway conditions and performing endotracheal intubation, the patient's anesthesia is maintained with isoflurane and oxygen/medical air based on the patient's hemodynamic status. During the procedure, mean arterial blood pressure (MAP) and heart rate are monitored every 3 minutes. In case of hypotension, a bolus of ephedrine 5 to 10 mg is first injected and repeated if necessary up to a maximum of 20 mg. If hypotension persists, norepinephrine infusion is initiated at a dose of 5–10 μg/min. At the end of the procedure, the patient is monitored and data are recorded for hemodynamic parameters during recovery. 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 Obtaining satisfaction from participants
public Tarokh Rajabinezhad
Bahonar Blvd
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 Tarokhrajabinezhad@gmail.com Qazvin University of Medical Sciences scientific Tarokh Rajabinezhad
Bahonar Blvd
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 tarokhrajabinezhad@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) People over 60 years of age who visit Shahid Rajaee Hospital in Qazvin and undergo orthopedic surgery due to a hip fracture 60 years no limit Both Allergy to ropivacaine Multiple trauma S72.0 Fracture of head and neck of femur Treatment - Drugs Treatment - Drugs Intervention group: Unilateral Spinal Anesthesia with Ropivacaine and Sufentanil: In this group, patients undergo Unilateral Spinal Anesthesia (ULSA). After injecting 500 cc of normal saline, the patient is placed in a sitting position. The hypobaric anesthetic solution is prepared with the following ingredients: 0.5% Ropivacaine, 2 ml (10 mg) of Sufentanil, 1 ml (5 μg) of distilled water, 1 ml. A total of 4 cc of the prepared solution is injected into the subarachnoid space L4–L5 (or a higher or lower space) with a 23 G needle. After injection, the patient is placed in a lateral position on the non-involved side (fracture area upwards) for 5 minutes to limit the spread of the drug to that side. In case of mild pain during the procedure (NRS <4), an opioid infusion is used. If the patient's pain is not controlled, general anesthesia is performed and the patient is excluded from the study. Monitoring of mean arterial blood pressure (MAP) and heart rate is performed every 3 minutes, as in the control group, and in case of hypotension, treatment with ephedrine and, if necessary, norepinephrine is performed. Control group: General anesthesia with isoflurane and standard induction drugs: In this group, patients are put under general anesthesia. After injecting 500 cc of normal saline and premedication with midazolam at a dose of 0.02 mg/kg, sufentanil at a dose of 0.2 μg/kg, propofol at a dose of 1 mg/kg, and atracurium at a dose of 0.5 mg/kg, anesthesia is used to induce anesthesia. After ensuring proper airway conditions and performing endotracheal intubation, the patient's anesthesia is maintained with isoflurane and oxygen/medical air based on the patient's hemodynamic status. During the procedure, mean arterial blood pressure (MAP) and heart rate are monitored every 3 minutes. In case of hypotension, a bolus of ephedrine 5 to 10 mg is first injected and repeated if necessary up to a maximum of 20 mg. If hypotension persists, norepinephrine infusion is initiated at a dose of 5–10 μg/min. At the end of the procedure, the patient is monitored and data are recorded for hemodynamic parameters during recovery. Severe hypotension during surgery. Timepoint: From the start of anesthesia to the end of the surgery. Method of measurement: Non-invasive blood pressure measurement with standard monitoring every three minutes. Intraoperative norepinephrine intake. Timepoint: From the start of anesthesia or numbing to the end of the surgery. Method of measurement: Total dose recorded on the anesthesia sheet. Amount of ephedrine taken during surgery. Timepoint: From the start of anesthesia or numbing to the end of the surgery. Method of measurement: Total dose recorded on the anesthesia sheet. Seven-day postoperative mortality. Timepoint: From the end of surgery to seven days later. Method of measurement: Clinical follow-up and hospital record review. Qazvin University of Medical Sciences Approved 2025-11-02 Ethics committee of Qazvin University of Medical Sciences Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd Qazvin Qazvin Iran (Islamic Republic of)