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Body Mass Index and Spinal Anesthesia in Urological Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653217
Enrollment
120
Registered
2026-06-17
Start date
2022-05-01
Completion date
2025-12-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Mass Index, Urologic Surgical Procedures, Vasopressor Therapy

Keywords

Body Mass Index, Ephedrine, Hemodynamic Response, Sensory Block

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.

Detailed description

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.

Interventions

None listed

Sponsors

Adiyaman University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative ephedrine consumption (mg)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

MeasureTime frameDescription
Maximum sensory block levelDuring intraoperative monitoringHighest thoracic dermatome level reached after intrathecal injection of 3 mL 0.5% hyperbaric bupivacaine, assessed by pinprick testing every 2 minutes.
Time to reach maximum sensory block (minutes)From intrathecal injection to maximum sensory levelTime in minutes from the intrathecal injection of hyperbaric bupivacaine until the maximum sensory block level is achieved.
Time to two-segment regression of sensory blockFrom maximum sensory block to two-dermatome regressionTime in minutes from the maximum sensory block level until regression of sensory block by two thoracic dermatomes.
Time to reach Bromage score 3From intrathecal injection to complete motor blockTime in minutes from the intrathecal injection until development of complete motor block in the lower extremities (Bromage score 3)
Motor block recovery time(minutes)From intrathecal injection to earliest detectable return of motor activityTime in minutes from the intrathecal injection until the earliest detectable return of motor function in the lower extremities.
Hemodynamic parametersBaseline 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026