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临床试验/NCT06048497
NCT06048497已完成不适用

The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section

Cukurova University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
The incidence of intra-operative hypotension

研究概览

简要总结

It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc < 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. On the other hand, patients with baseline FTc > 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 20-40 years of age pregnant women
  • American Society of Anesthesiologists (ASA) physical status-II patients
  • Uncomplicated, singleton, term pregnancy
  • Elective C/S surgery

排除标准

  • Placental disorders
  • Gestational hypertensive disorders
  • Morbid obesity (BMI>39 kg/m2)
  • Carotid stenosis more than 50%
  • Baseline SAP more than 160 mmHg
  • Arrhythmia
  • History of cardiovascular or cerebrovascular disease, and chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m2)
  • Emergency surgery

结局指标

主要结局

The incidence of intra-operative hypotension

时间窗: During surgery

Hypotension definitions included systolic arterial pressure (SAP) below 80 mmHg, or mean arterial pressure (MAP) below 65 mmHg, or a decrease in SAP of more than 30% below baseline, or a decrease in MAP of more than 20% below baseline, or any combination of all these definitions.

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

Demet Laflı Tunay

Principal Investigator

Cukurova University

研究点 (2)

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