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NCT Number: NCT07445451

Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia

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.

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Key information

Conditions

Bladder Tumors Dexmedetomidine Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodynamic and Respiratory Monitoring Magnesium Sulfate Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Spinal Anesthesia Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBÜ Kartal Dr. Lütfi Kırday City Hospital, İstanbul

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Magnesium sulfate

Drug

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.

Dexmedetomidine

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. 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.

  2. Total Postoperative Analgesic Consumption

    Time frame: 24 hours postoperative

    Total amount of analgesics (paracetamol and tramadol) administered within 24 hours after surgery.

  3. 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

  1. Integrated Pulmonary Index (IPI)

    Time frame: During surgery

    Respiratory effort and ventilatory adequacy measured intraoperatively.

  2. Intraoperative heart rate

    Time frame: During surgery

    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).

  3. Intraoperative systolic blood pressure

    Time frame: During surgery

    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).

  4. Intraoperative diastolic blood pressure

    Time frame: During surgery

    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).

  5. Intraoperative mean arterial pressure

    Time frame: During surgery

    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).

  6. Adverse Effects

    Time frame: Intraoperative and 24 hours postoperative

    Incidence of hypotension, bradycardia, desaturation, postoperative nausea and vomiting, and other side effects.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: TURBT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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