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临床试验/NCT06869434
NCT06869434已完成不适用

In Cesarean Sections, is the Length of the Thoracolumbar Vertebral Column Applicable for Determining the Dosage of Bupivacaine in Spinal Anesthesia?

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 446 人开始时间: 2025年5月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
446
试验地点
2
主要终点
Hypotension rate among the groups

研究概览

简要总结

Our hypothesis is that the bupivacaine dose determined according to the thoracolumbar vertebral body length (VBL) is more effective in achieving a lower hypotension rate during spinal anesthesia for cesarean delivery than the dose usually adjusted based on height and weight. The VBL measurements were determined from the midpoint of C7 to the tuffier line L4 spinous process.

Method: Patients ranging in height from 150 to 170 were randomly assigned to either Group 1 (0.2 mg of 0.5% hyperbaric bupivacaine per cm VBL or Group 2 (height-adjusted dose of 0.5% hyperbaric bupivacaine based on a minimum dose of 0.065 mg/cm according to height) or Group 3 (height-adjusted dose of 0.5% hyperbaric bupivacaine based on a minimum height-adjusted dose of 0.065 mg/cm).

详细描述

The study followed a parallel study strategy. Patients provided informed permission before the procedure. The study was randomly assigned and blinded. The study was conducted from April 2025 to December 2025. Patients with pre-existing or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, contraindications to spinal anesthesia, weighing < 50 kg or > 110 kg, and heights higher than 170 cm or shorter than 150 cm were eliminated. Informed written consent was acquired from all patients participating in the trial. Each patient was evaluated for vital parameters and possible complications at 3-minute intervals before and after the spinal anesthesia application, treated if necessary, and recorded. The study was concluded at the end of the cesarean section.

There was no premeditation among the patients. The patient had standard monitoring, including non-invasive blood pressure, ECG, and pulse oximetry, with recorded baseline blood pressure and heart rate measurements. We inserted two 20-gauge intravenous cannulas and administered an IV-balanced solution using these routes. The patients' age, height, weight, ASA class, and VBL (C7-L4 Tuffier line cm) were recorded. The Tuffier's line (TL), which is made by drawing a horizontal line across the tops of the iliac crests, is the most common anatomical landmark right now. It has been shown to match up with the L4-L5 interspace or the L4 spinous process.

After skin infiltration with 2% lidocaine, a 25-gauge short-bevel Quincke spinal needle was placed at the L3-4 vertebral interspace with the patient in a sitting position. After aspiration of cerebrospinal fluid, the following anesthetic solutions were delivered over 5 seconds. Randomization was used to divide the patients into three groups. The trial was double-blind, with the patient and assessor unconscious of their group allocation. Only the practitioner delivering the spinal anesthesia was aware of the group allocation. Systolic, diastolic, and mean arterial blood pressure and heart rate were documented at baseline and assessed at 3-minute intervals, commencing 3 minutes post-spinal injection and persisting until the initiation of surgical procedures, after which measurements were conducted at 3-minute intervals.

Patients in Group VBL (Vertebral Body Length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine. In contrast, Group FD (fixed dose) received a 0.5% hyperbaric bupivacaine volume based on a dose calculated according to the patient's height of 0.065 mg/cm. Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Class II
  • Having regular antenatal visits
  • Singleton pregnancy at ≥37 weeks of gestation
  • Pregnant women aged 18-45 -

排除标准

  • Those with eclampsia, those with preeclampsia
  • Undergoing an emergency cesarean section
  • Those with bleeding diathesis and those receiving anticoagulant therapy
  • With a history of carotid artery stenosis,
  • Cardiovascular disease,
  • Hypertension,
  • Chronic obstructive pulmonary disease,
  • Heart rhythm outside of sinus
  • Patients with a history of cerebrovascular disease
  • Alcoholism or psychiatric illness
  • Placenta previa, accreta, and percreta

研究组 & 干预措施

Group VBL (Vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine,

Active Comparator

Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine

干预措施: Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine (Procedure)

Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated ac

Active Comparator

Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm

干预措施: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm (Procedure)

Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height

Active Comparator

Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight

干预措施: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. (Procedure)

结局指标

主要结局

Hypotension rate among the groups

时间窗: From the patient's arrival in the operating room to the end of the surgery

Our hypothesis is that the bupivacaine dose determined according to the thoracolumbar vertebral body length (VBL) is more effective in achieving a lower hypotension rate during spinal anesthesia for cesarean delivery than the dose usually adjusted based on height and weight.

Hypotension Rate Among the Groups

时间窗: From initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes)

Maternal hypotension was defined as a decrease in systolic blood pressure of more than 20% from baseline or a systolic blood pressure \<90 mmHg. The incidence of hypotension was recorded intraoperatively for each participant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kudret Dogru

Professor. Dr.

TC Erciyes University

研究点 (2)

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