NCT07445451

Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Tumors
• Spinal Anesthesia
• Postoperative Pain
• Magnesium Sulfate
• Dexmedetomidine
• Hemodynamic and Respiratory Monitoring

Interventions

Type	Name	Description
DRUG	magnesium sulfate	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.
DRUG	Dexmedetomidine	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.
DRUG	Normal Saline	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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-09-01
• Completion: 2025-12-15
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Turkey (Türkiye)