Body Mass Index and Spinal Anesthesia in Urological Surgery
2026年6月16日 更新者：Fadime Tosun、Adiyaman University
The Effect of Body Mass Index on Vasopressor Use, Block Dynamics, and Hemodynamic Responses in Urological Surgery Cases Undergoing Spinal Anesthesia: Prospective Observational Study
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Adıyaman Province
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Merkez、Adıyaman Province、土耳其（türkiye）、02100
- Adıyaman University Faculty of Medicine Anesthesiology and Reanimation
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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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
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative ephedrine consumption (mg)
大体时间：From spinal anesthesia induction until completion of surgery.
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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.
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From spinal anesthesia induction until completion of surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum sensory block level
大体时间：During intraoperative monitoring
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Highest thoracic dermatome level reached after intrathecal injection of 3 mL 0.5% hyperbaric bupivacaine, assessed by pinprick testing every 2 minutes.
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During intraoperative monitoring
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Time to reach maximum sensory block (minutes)
大体时间：From intrathecal injection to maximum sensory level
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Time in minutes from the intrathecal injection of hyperbaric bupivacaine until the maximum sensory block level is achieved.
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From intrathecal injection to maximum sensory level
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Time to two-segment regression of sensory block
大体时间：From maximum sensory block to two-dermatome regression
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Time in minutes from the maximum sensory block level until regression of sensory block by two thoracic dermatomes.
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From maximum sensory block to two-dermatome regression
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Time to reach Bromage score 3
大体时间：From intrathecal injection to complete motor block
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Time in minutes from the intrathecal injection until development of complete motor block in the lower extremities (Bromage score 3)
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From intrathecal injection to complete motor block
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Motor block recovery time(minutes)
大体时间：From intrathecal injection to earliest detectable return of motor activity
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Time in minutes from the intrathecal injection until the earliest detectable return of motor function in the lower extremities.
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From intrathecal injection to earliest detectable return of motor activity
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Hemodynamic parameters
大体时间：Baseline and every 5 minutes during surgery.,
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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.
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Baseline and every 5 minutes during surgery.,
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月1日
初级完成 (实际的)
2025年12月1日
研究完成 (实际的)
2025年12月1日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- ADYU-AR-FT-03
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