Body Mass Index and Spinal Anesthesia in Urological Surgery

NCT07653217 | Completed

• 1 other identifier: ADYU-AR-FT-03
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urologic Surgical Procedures; Body Mass Index; Vasopressor Therapy

Keywords

Body Mass Index; Ephedrine; Hemodynamic Response; Sensory Block

Outcome Measures

Primary Outcomes (1)

• Intraoperative ephedrine consumption (mg)

  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.

  From spinal anesthesia induction until completion of surgery.

Secondary Outcomes (6)

• Maximum sensory block level

  During intraoperative monitoring

• Time to reach maximum sensory block (minutes)

  From intrathecal injection to maximum sensory level

• Time to two-segment regression of sensory block

  From maximum sensory block to two-dermatome regression

• Time to reach Bromage score 3

  From intrathecal injection to complete motor block

• Motor block recovery time(minutes)

  From intrathecal injection to earliest detectable return of motor activity

Study Arms (2)

BMI <27.5 kg/m² (Group L)

Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) \<27.5 kg/m²

BMI ≥27.5 kg/m² (Group H)

Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) ≥27.5 kg/m².

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with ASA physical status I-II scheduled for elective urological surgery in the lithotomy position under spinal anesthesia at a tertiary care hospital. All participants had a BMI ≥18.5 kg/m² and were classified into two groups according to BMI (Group L: BMI \<27.5 kg/m², Group H: BMI ≥27.5 kg/m²). Patients with contraindications to spinal anesthesia, extreme height (\<150 cm or \>190 cm), or who declined participation were excluded.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University Faculty of Medicine Anesthesiology and Reanimation

Merkez, Adıyaman Province, 02100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: May 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)