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临床试验/NCT07549152
NCT07549152已完成不适用

Does the Pre-induction Lithotomy Position Reduce Post-induction Hypotension in Geriatric Hypertensive Patients? A Prospective Randomized Study

Trabzon Karadeniz Teknik Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Incidence of Post-induction Hypotension (PIH)

研究概览

简要总结

Anesthesia-induced hypotension is a common occurrence in elderly hypertensive patients and is closely associated with increased postoperative morbidity

  • This study aims to investigate whether the lithotomy position, a non-pharmacological and cost-free approach, can reduce the incidence of post-induction hypotension (PIH) in this high-risk population by increasing venous return

Sixty patients aged 65-80 with a history of hypertension were randomly assigned to either the Supine Group (Group S) or the Lithotomy Group (Group L)

  • In Group L, patients were placed in the lithotomy position 120 seconds before the start of anesthesia induction
  • Blood pressure was monitored every minute for the first five minutes following induction
  • The study evaluates whether this simple positioning strategy can maintain hemodynamic stability, reduce the drop in mean arterial pressure, and decrease the overall need for vasopressor medications like ephedrine

详细描述

This prospective, randomized clinical study was conducted at Karadeniz Technical University Faculty of Medicine after receiving ethics committee approval (Protocol No: 2021/268)

  • The study included 60 patients aged 65-80, classified as ASA II-III, who had been diagnosed with hypertension and on stable medication for at least 6 months

Randomization and Blinding: Participants were randomized into two groups (n=30 each) using computer-based random number generation

  • Allocation was concealed using sequentially numbered envelopes
  • Researchers involved in data recording and statistical analysis were blinded to the group assignments

Anesthesia Protocol: All patients received standard monitoring (ECG, SpO₂, and non-invasive blood pressure) and were sedated with intravenous midazolam (0.05 mg/kg) and fentanyl (1 µg/kg)

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

Researchers involved in hemodynamic data recording and statistical analysis were blinded to the group assignments

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

  • Aged between 65 and 80 years.
  • American Society of Anesthesiologists (ASA) physical status class II or III.
  • Clinical diagnosis of hypertension.
  • Continuous use of the same antihypertensive medication for at least 6 months.
  • Scheduled for elective surgery requiring the lithotomy position.

排除标准

  • Uncontrolled hypertension.
  • Arrhythmias requiring medical treatment.
  • Left ventricular ejection fraction (LVEF) < 40%.
  • Unstable ischemic heart disease.
  • Physical inability to be placed in the lithotomy position.

研究组 & 干预措施

Group S (Supine Position Group)

Active Comparator

Patients in this group undergo anesthesia induction in the standard supine position

干预措施: Standard Supine Position (Other)

Group L (Lithotomy Position Group

Experimental

Patients in this group are placed in the lithotomy position before the start of anesthesia induction to evaluate its effect on hemodynamic stability

干预措施: Pre-induction Lithotomy Position (Other)

结局指标

主要结局

Incidence of Post-induction Hypotension (PIH)

时间窗: Within the first 5 minutes following the completion of anesthesia induction (measurements recorded at minutes 0, 1, 2, 3, 4, and 5)

Post-induction hypotension is defined as a Mean Arterial Pressure (MAP) falling below 65 mmHg or a decrease of more than 20% from the baseline value

次要结局

  • Time to Onset of First Hypotension(Within the first 5 minutes after anesthesia induction)

研究者

发起方
Trabzon Karadeniz Teknik Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samet Kandemir

Research Assistant, Department of Anesthesiology and Reanimatio

Trabzon Karadeniz Teknik Universitesi

研究点 (1)

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