A Randomized Controlled Trial of the Analgesic, Hemodynamic, and Respiratory Effects of Intravenous Magnesium Sulfate and Dexmedetomidine Infusions During Transurethral Bladder Tumor Resection Under Spinal Anesthesia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Total Postoperative Analgesic Consumption
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 85 years. Classified as ASA physical status I, II, or III according to the American Society of Anesthesiologists.
- •Patients scheduled for elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia.
Exclusion Criteria
- •Patients under 18 years or over 85 years of age. Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy).
- •History or current diagnosis of significant cardiac arrhythmia. Known allergy or contraindication to the study drugs (magnesium sulfate or dexmedetomidine).
- •Patients requiring conversion to general anesthesia due to inadequate spinal anesthesia intraoperatively.
- •Mental retardation, cognitive impairment, or communication difficulties that prevent understanding of study procedures or pain assessment.
- •Patients who refuse to participate in the study.
Arms & Interventions
Magnesium Sulfate Infusion Group
Patients receive intravenous magnesium sulfate at 15 mg/kg/hour during TUR-M surgery under spinal anesthesia. Infusion solution is prepared aseptically by diluting the calculated dose in 50 mL of 0.9% NaCl. Postoperative analgesia is administered as rescue treatment based on VAS scores.
Intervention: magnesium sulfate (Drug)
Dexmedetomidine Infusion Group
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% NaCl and infused intravenously. Postoperative analgesia is given as rescue treatment according to VAS scores.
Intervention: Dexmedetomidine (Drug)
Control Group (Saline Infusion)
Patients receive intravenous normal saline at 15 mL/kg/hour during TUR-M surgery under spinal anesthesia. Infusion is administered with the same protocol and devices as the experimental arms to maintain blinding. Postoperative analgesia is provided as rescue treatment based on VAS scores.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Total Postoperative Analgesic Consumption
Time Frame: 24 hours postoperative
Total amount of analgesics (paracetamol and tramadol) administered within 24 hours after surgery.
Time to First Analgesic Request
Time Frame: Postoperative period up to 24 hours
Time (in minutes) from the end of surgery until the patient first requests postoperative analgesia.
Postoperative Pain Scores
Time Frame: 24 hours postoperative
Pain intensity measured using the Visual Analog Scale (VAS) at the end of surgery, 60 minutes, 6 hours, and 24 hours after surgery.
Secondary Outcomes
- Integrated Pulmonary Index (IPI)(During surgery)
- Intraoperative heart rate(During surgery)
- Intraoperative systolic blood pressure(During surgery)
- Intraoperative diastolic blood pressure(During surgery)
- Intraoperative mean arterial pressure(During surgery)
- Adverse Effects(Intraoperative and 24 hours postoperative)
Investigators
Halil Ibrahım Yuksel
Resident Physician, Department of Anesthesiology and Reanimation
Dr. Lutfi Kirdar Kartal Training and Research Hospital