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Dural Sac Area-Guided Spinal Anesthesia Dosing for TURP

NCT07794852 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-31

No results posted yet for this study

Summary

This randomized controlled study will evaluate whether individualizing the dose of spinal anesthesia according to the ultrasound-derived dural sac cross-sectional area (DSCSA) can improve hemodynamic stability in patients undergoing transurethral resection of the prostate (TURP).

Participants aged 40 years or older will be randomly assigned to one of two groups. In the individualized-dose group, the anteroposterior diameter of the dural sac will be measured by ultrasound at the L3-L4 level, and DSCSA will be calculated from this measurement. The dose of intrathecal bupivacaine will then be individualized according to the calculated DSCSA. In the control group, participants will receive a fixed dose of intrathecal bupivacaine. Both groups will also receive intrathecal fentanyl.

The main outcome is the incidence of intraoperative hypotension. The study will also evaluate the number of hypotensive episodes, minimum mean arterial pressure, vasopressor and atropine requirements, sensory and motor block characteristics, respiratory monitoring parameters, cerebral oxygenation, and adverse events.

The study aims to determine whether a DSCSA-guided dosing strategy can reduce excessive spinal block and improve hemodynamic stability while maintaining effective spinal anesthesia.

Conditions

  • Intraoperative Hypotension
  • Spinal Aneshtesia
  • TURP(Transurethral Resection of Prostate)

Interventions

PROCEDURE

DSCSA-Guided Individualized Spinal Anesthesia Dosing

The dural sac cross-sectional area (DSCSA) is calculated from the ultrasound-measured anteroposterior dural sac diameter at the L3-L4 level. The intrathecal bupivacaine dose is individualized according to DSCSA.

DRUG

Bupivacaine

Hyperbaric bupivacaine is administered intrathecally in both study groups. In the DSCSA-guided group, the dose is individualized according to DSCSA, using 150 mm² as the reference corresponding to 10 mg, with a permitted dose range of 6 to 12.5 mg. In the fixed-dose group, 10 mg (2 mL of 0.5% bupivacaine) is administered.

DRUG

Fentanyl (FEN)

Fentanyl 25 micrograms is administered intrathecally together with bupivacaine in both study groups.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Ezgi Budak Özyalçın, MD · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2026-11-24
Completion
2026-12-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794852 on ClinicalTrials.gov