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临床试验/NCT03721536
NCT03721536已完成不适用

Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial

Inonu University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年10月18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
入组人数
48
试验地点
2
主要终点
The level of partial oxygen pressure

研究概览

简要总结

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

详细描述

Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
  • Aged 18-65 years old,

排除标准

  • Uncontrolled diabetes mellitus,
  • Cardiovascular disease,
  • Pulmonary disease,
  • Cerebrovascular disease,
  • Drug and alcohol addiction.

研究组 & 干预措施

low-flow anesthesia

Active Comparator

Patients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.

干预措施: hemodynamic parameters (Diagnostic Test)

low-flow anesthesia

Active Comparator

Patients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.

干预措施: arterial blood gase (Diagnostic Test)

normal-flow anesthesia

Active Comparator

Patients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.

干预措施: hemodynamic parameters (Diagnostic Test)

normal-flow anesthesia

Active Comparator

Patients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.

干预措施: arterial blood gase (Diagnostic Test)

结局指标

主要结局

The level of partial oxygen pressure

时间窗: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis

次要结局

  • Mean arterial pressure(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))
  • Heart rate(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))
  • Peripheral oxygen saturation(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))

研究者

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

Sedat AKBAS

Asst. Prof. Dr. Sedat Akbas

Inonu University

研究点 (2)

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