This randomized controlled trial evaluated the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine on postoperative pain, analgesic consumption, hemodynamic stability, and respiratory function in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Magnesium sulfate significantly reduced postoperative pain scores, delayed the time to first analgesic request, and decreased total analgesic consumption compared to dexmedetomidine and control groups, while both agents were hemodynamically and respiratorily safe.
This study is a prospective, randomized, controlled trial designed to evaluate the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine infusions in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Adult patients (age 18-85 years) with ASA physical status I-III scheduled for TUR-M were enrolled. Participants were randomly assigned to receive either magnesium sulfate, dexmedetomidine, or saline infusion during surgery. All patients received standardized spinal anesthesia. The study assesses postoperative pain, analgesic consumption, hemodynamic and respiratory parameters, and side effects. The trial aims to determine which agent provides better postoperative analgesia while maintaining cardiovascular and respiratory safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Patients receive intravenous magnesium sulfate at 15 mg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.
Patients receive intravenous dexmedetomidine at 0.5 µg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.
Patients receive 15 mL/kg/hour of 0.9% sodium chloride without active pharmacological agents during TUR-M surgery under spinal anesthesia. Infusion is administered using the same protocol and devices as the experimental arms to maintain blinding. Postoperative analgesia is provided as rescue treatment based on VAS scores.
SBÜ Kartal Dr. Lütfi Kırday City Hospital, İstanbul
Istanbul, Turkey (Türkiye)
Time to First Analgesic Request
Time (in minutes) from the end of surgery until the patient first requests postoperative analgesia.
Time frame: Postoperative period up to 24 hours
Total Postoperative Analgesic Consumption
Total amount of analgesics (paracetamol and tramadol) administered within 24 hours after surgery.
Time frame: 24 hours postoperative
Postoperative Pain Scores
Pain intensity measured using the Visual Analog Scale (VAS) at the end of surgery, 60 minutes, 6 hours, and 24 hours after surgery.
Time frame: 24 hours postoperative
Integrated Pulmonary Index (IPI)
Respiratory effort and ventilatory adequacy measured intraoperatively.
Time frame: During surgery
Intraoperative heart rate
Heart rate will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative heart rate will be recorded and reported in beats per minute (bpm).
Time frame: During surgery
Intraoperative systolic blood pressure
Systolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative systolic blood pressure will be recorded and reported in millimeters of mercury (mmHg).
Time frame: During surgery
Intraoperative diastolic blood pressure
Diastolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative diastolic blood pressure will be recorded and reported in millimeters of mercury (mmHg).
Time frame: During surgery
Intraoperative mean arterial pressure
Mean arterial pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative MAP values will be recorded and reported in millimeters of mercury (mmHg).
Time frame: During surgery
Adverse Effects
Incidence of hypotension, bradycardia, desaturation, postoperative nausea and vomiting, and other side effects.
Time frame: Intraoperative and 24 hours postoperative
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