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临床试验/NCT05749328
NCT05749328尚未招募不适用

Effect of Preoperative Oral Carbohydrate Shortening the Fasting Period on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 210 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
210
主要终点
Incidence of hypotension

研究概览

简要总结

The goal of this Randomized controlled trial is to investigate the effect of shortening the duration of preoperative oral carbohydrate drinks on blood pressure after anesthesia induction in elderly patients undergoing joint replacement surgery. The main question it aims to answer is Whether preoperative oral carbohydrate drinks can reduce the incidence of hypotension after anesthesia-induced hypotension in elderly patients undergoing joint replacement surgery.According to the numerical table method, the patients in the experimental group will drink carbohydrate drinks the night before the operation and 3 hours before the operation, and the control group patients will routinely fast

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing elective unilateral joint replacement (total hip or knee)

排除标准

  • Diagnosed patients at high risk of reflux aspiration (diabetes mellitus, obesity (BMI>30), gastrointestinal obstruction, elevated intracranial pressure, and esophageal disease)
  • Eating disorders
  • History of gastrointestinal or epigastric surgery
  • Recent use of drugs that affect gastrointestinal motility
  • Heart disease (severe arrhythmias, severe heart valve disease, heart failure, unstable angina on the day of surgery)
  • Severe poorly controlled hypertension (MAP≥135 mmHg) or hypotension (MAP≤55 mmHg) before induction
  • Difficult airway
  • Severe hepatic and renal insufficiency

结局指标

主要结局

Incidence of hypotension

时间窗: 20 minutes after induction of anesthesia

No surgical manipulation is performed within 20 minutes

次要结局

  • Duration of fasting and drinking(1 day before the operation)
  • Incidence of hypotension(during the whole operation)
  • Antral cross-sectional area(30 minutes before anesthesia induction)
  • The dosage of vasoactive drugs(20 minutes after induction of anesthesia)
  • Thirst and hunger VAS score(3 hours before and 1 day after the operation)
  • Fasting blood glucose and insulin resistance index(3 hours before the operation)
  • Incidence of nausea and vomiting(1 day after the operation)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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