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NCT Number: NCT07653217

Body Mass Index and Spinal Anesthesia in Urological Surgery

This single-center prospective observational study investigates the effect of body mass index (BMI) on intraoperative vasopressor requirements and spinal block characteristics in adult patients undergoing urological surgery under spinal anesthesia. Participants are classified into two cohorts according to BMI (<27.5 kg/m² and ≥27.5 kg/m²).Patient enrollment for this prospective observational study started before trial registration; therefore, this record represents a retrospective registration.

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Key information

Conditions

Urologic Surgical Procedures Body Mass Index Vasopressor Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adıyaman University Faculty of Medicine Anesthesiology and Reanimation

Merkez, Adıyaman Province, 02100, Turkey (Türkiye)

About this study

This is a single-center prospective observational study conducted at a tertiary care hospital between May 2022 and December 2025. The study aims to evaluate the relationship between body mass index (BMI) and intraoperative ephedrine requirements, sensory and motor block characteristics, and hemodynamic responses in adult patients undergoing elective urologic surgery in the lithotomy position under spinal anesthesia. All patients received a standardized intrathecal dose of 3 mL 0.5% hyperbaric bupivacaine, and intraoperative hypotension was treated with intravenous ephedrine according to a predefined protocol. Patient enrollment for this prospective observational study began before registration of the study; therefore, this record represents a retrospective registration. Ethics approval was obtained from the institutional ethics committee prior to patient recruitment, and written informed consent was obtained from all participants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective urologic surgery under spinal anesthesia

Exclusion criteria

  • Refusal to participate or lack of informed consent
  • Contraindications to spinal anesthesia
  • Height <150 cm or >190 cm
  • BMI <18.5 kg/m²

Treatment and study plan

Primary outcomes

  1. Intraoperative ephedrine consumption (mg)

    Time frame: From spinal anesthesia induction until completion of surgery.

    Cumulative intravenous ephedrine dose administered to treat hypotension (systolic arterial pressure <90 mmHg or >30% decrease from baseline) from the time of spinal anesthesia induction until the end of the surgical procedure.

Secondary outcomes

  1. Maximum sensory block level

    Time frame: During intraoperative monitoring

    Highest thoracic dermatome level reached after intrathecal injection of 3 mL 0.5% hyperbaric bupivacaine, assessed by pinprick testing every 2 minutes.

  2. Time to reach maximum sensory block (minutes)

    Time frame: From intrathecal injection to maximum sensory level

    Time in minutes from the intrathecal injection of hyperbaric bupivacaine until the maximum sensory block level is achieved.

  3. Time to two-segment regression of sensory block

    Time frame: From maximum sensory block to two-dermatome regression

    Time in minutes from the maximum sensory block level until regression of sensory block by two thoracic dermatomes.

  4. Time to reach Bromage score 3

    Time frame: From intrathecal injection to complete motor block

    Time in minutes from the intrathecal injection until development of complete motor block in the lower extremities (Bromage score 3)

  5. Motor block recovery time(minutes)

    Time frame: From intrathecal injection to earliest detectable return of motor activity

    Time in minutes from the intrathecal injection until the earliest detectable return of motor function in the lower extremities.

  6. Hemodynamic parameters

    Time frame: Baseline and every 5 minutes during surgery.,

    Noninvasive systolic and diastolic arterial pressure and heart rate measured at baseline (before spinal anesthesia) and then at 5-minute intervals throughout the surgical procedure.

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Official study title

The Effect of Body Mass Index on Vasopressor Use, Block Dynamics, and Hemodynamic Responses in Urological Surgery Cases Undergoing Spinal Anesthesia: Prospective Observational Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 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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