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临床试验/NCT05891951
NCT05891951招募中不适用

Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery

Min Su1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Occurrence of hypotension after anesthesia induction

研究概览

简要总结

The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.

The main question[s] it aims to answer are:

Whether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.

Whether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.

Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.

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
Single (Outcomes Assessor)

盲法说明

In this study, researchers and subjects were not blind. Anesthesiologists and data collectors were blind. Researchers conducted carotid ultrasound guided fluid therapy for experimental groups according to the groups, anesthesiologists performed routine induction for patients in the two groups, data collectors collected data, and anesthesiologists and data collectors did not know the groups of subjects.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60-80 years old
  • gender unlimited
  • ASA: Grade I-Ⅲ
  • BMI:18-30kg/㎡
  • Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent

排除标准

  • Carotid artery stenosis ≥50%
  • Patients with heart valve disease
  • Patients with left ventricular ejection fraction < 50%
  • Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)
  • Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen > 9mmol/L)
  • Preoperative systolic blood pressure> 160mmHg or diastolic blood pressure > 100mmHg
  • Refuse to participate in the test
  • Patients participating in other clinical trials

结局指标

主要结局

Occurrence of hypotension after anesthesia induction

时间窗: General anesthesia induction from the beginning to 20 minutes after induction

Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.

次要结局

  • postoperative delirium(Within 30 days after surgery)
  • Postoperative acute kidney injury(Within 7 days after surgery)
  • postoperative stroke(Within 30 days after surgery)

研究者

发起方
Min Su
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min Su

Director,Principal Investigator, Clinical Professor

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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