Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia

NCT07445451 | Completed

• 1 other identifier: DrLutfiKirdarTRH-ANES-HY-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

postoperative analgesia; Integrated Pulmonary Index; TURBT

Outcome Measures

Primary Outcomes (3)

• Time to First Analgesic Request

  Time (in minutes) from the end of surgery until the patient first requests postoperative analgesia.

  Postoperative period up to 24 hours

• Total Postoperative Analgesic Consumption

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

  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.

  24 hours postoperative

Secondary Outcomes (6)

• 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

Study Arms (3)

Magnesium Sulfate Infusion Group

EXPERIMENTAL

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.

Drug: magnesium sulfate

Dexmedetomidine Infusion Group

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Control Group (Saline Infusion)

ACTIVE COMPARATOR

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.

Drug: Normal Saline

Interventions

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.

Magnesium Sulfate Infusion Group

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.

Dexmedetomidine Infusion Group

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.

Control Group (Saline Infusion)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

SBÜ Kartal Dr. Lütfi Kırday City Hospital, İstanbul

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Pain, Postoperative

Interventions

Magnesium Sulfate; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Model Details: This is an interventional study with a parallel assignment model. Participants are randomly assigned to one of three groups (Magnesium Sulfate, Dexmedetomidine, or Control), and each group is observed independently and concurrently. The study is single-blind, meaning that the investigators and the statistician analyzing the data are unaware of the assigned infusion type, while participants do not know which group they are in. The primary purpose of the study is treatment, aiming to evaluate the intraoperative effects of magnesium sulfate and dexmedetomidine on postoperative analgesia, hemodynamic stability, and respiratory function.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 3, 2026
• Study Start: December 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 15, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)