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Bladder TumorsTURBTNCT07445451

Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia

A study testing magnesium sulfate, Dexmedetomidine and Normal Saline in people with Bladder Tumors and Spinal Anesthesia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
magnesium sulfate, Dexmedetomidine and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2024to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • SBÜ Kartal Dr. Lütfi Kırday City Hospital, İstanbul

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the 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.

Being tested
magnesium sulfate, Dexmedetomidine, Normal Saline
Keywords
postoperative analgesia, Integrated Pulmonary Index, TURBT
Medical subject headings
Urinary Bladder Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • magnesium sulfateDrug

    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.

  • DexmedetomidineDrug

    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 SalineDrug

    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.

Study groups in NCT07445451
Study groupRoleWhat they receive
Magnesium Sulfate Infusion GroupExperimentalPatients 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.
Receives: Drug: magnesium sulfate
Dexmedetomidine Infusion GroupExperimentalPatients 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.
Receives: Drug: Dexmedetomidine
Control Group (Saline Infusion)Active comparatorPatients 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.
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Analgesic Request

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

    Measured: Postoperative period up to 24 hours

  2. Total Postoperative Analgesic Consumption

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

    Measured: 24 hours postoperative

  3. 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.

    Measured: 24 hours postoperative

Secondary outcomes (6)

  1. Integrated Pulmonary Index (IPI)

    Respiratory effort and ventilatory adequacy measured intraoperatively.

    Measured: During surgery

  2. 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).

    Measured: During surgery

  3. 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).

    Measured: During surgery

  4. 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).

    Measured: During surgery

  5. 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).

    Measured: During surgery

  6. Adverse Effects

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

    Measured: Intraoperative and 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start15 Dec 2024
  3. Primary completion1 Sep 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07445451
Sponsor's protocol ID
DrLutfiKirdarTRH-ANES-HY-01
Acronym
TURBT
Status last verified
Feb 2026
First submitted
16 Feb 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) will not be shared publicy due to local data privacy regulations and institutional policy. Aggregate results will be available in published form.

Questions about this trial

What is this clinical trial studying?

A study testing magnesium sulfate, Dexmedetomidine and Normal Saline in people with Bladder Tumors and Spinal Anesthesia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Analgesic Request (time frame: Postoperative period up to 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07445451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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