此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

连续输注右美托咪定对腹腔镜胆囊切除术中全身微血管功能的影响

2026年11月3日 更新者:Eduardo Tibirica, MD, PhD、National Institute of Cardiology, Laranjeiras, Brazil

持续右美托咪定输注对腹腔镜胆囊切除术患者全身微血管功能影响的前瞻性研究

The microcirculation represents the primary site of exchange of oxygen and nutrients for tissues, and the preservation of microcirculatory perfusion is essential for the maintenance of organ function. The microcirculation is extremely dynamic and may vary according to the individual's temperature, systemic blood pressure, the use of medications, during physical and mental activity, age and pathological processes. In this context, the development of portable microscopes for clinical use has made possible the non-invasive visualization of the microcirculation and tissue perfusion in patients undergoing several highly complex procedures in cardiology, including cardiac surgery with cardiopulmonary bypass, ECMO (Extracorporeal Membrane Oxygenation) and in critically ill patients in intensive care.

CytoCam, for example, is a handheld device that incorporates a darkfield incident light illumination system with a series of high-resolution lenses that project images to a computer dedicated to the system. Dexmedetomidine is a selective agonist of 2-adrenergic receptors in the central nervous system, whose administration results in a reduction in the activity of the sympathetic nervous system and a reduction in the systemic release of catecholamines. Its use in the perioperative period has several beneficial effects, such as reducing neuroendocrine and hemodynamic responses due to anesthesia and surgery, through induction of sedation and analgesia, in addition to reducing the consumption of opioids and anesthetics in general. Several recent studies report that the use of dexmedetomidine in the perioperative period reduces the incidence of postoperative complications, reduces the time on mechanical ventilation and attenuates the neuroendocrine response due to surgical trauma and extracorporeal circulation in patients undergoing cardiac surgery. However, the effects of dexmedetomidine on systemic microcirculation function during its use in anesthesia for elective surgical procedures of medium complexity are not yet known. In conclusion, the hypothesis of the present study is that continuous intravenous infusion of dexmedetomidine during balanced general anesthesia increases the microvascular perfusion flow rate in the sublingual mucosa, representing an increase in systemic microvascular perfusion.

研究概览

详细说明

CytoCam, is a handheld device that incorporates a darkfield incident light illumination system with a series of high-resolution lenses that project images to a computer dedicated to the system. Dexmedetomidine is a selective agonist of 2-adrenergic receptors in the central nervous system, whose administration results in a reduction in the activity of the sympathetic nervous system and a reduction in the systemic release of catecholamines. Its use in the perioperative period has several beneficial effects, such as reducing neuroendocrine and hemodynamic responses due to anesthesia and surgery, through induction of sedation and analgesia, in addition to reducing the consumption of opioids and anesthetics in general. Several recent studies report that the use of dexmedetomidine in the perioperative period reduces the incidence of postoperative complications, reduces the time on mechanical ventilation and attenuates the neuroendocrine response due to surgical trauma and extracorporeal circulation in patients undergoing cardiac surgery. However, the effects of dexmedetomidine on systemic microcirculation function during its use in anesthesia for elective surgical procedures of medium complexity are not yet known. In conclusion, the hypothesis of the present study is that continuous intravenous infusion of dexmedetomidine during balanced general anesthesia increases the microvascular perfusion flow rate in the sublingual mucosa, representing an increase in systemic microvascular perfusion.

研究类型

介入性

注册 (实际的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Rio de Janeiro、巴西、22240006
        • Eduardo Tibiriçá

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients of both sexes (age ≥ 18 and ≤ 75 years)
  • Physical state ASA I or II according to the criteria of the American Association of Anesthesiology
  • Planned surgery of cholecystectomy by videolaparoscopy

Exclusion Criteria:

  • Patient's refusal to participate in the study
  • Inflammation or infection in the sublingual mucosa
  • Emergency surgery
  • Grade III obesity (BMI ≥39.9 kg/m2)
  • Pregnancy or lactation
  • Autoimmune diseases, malignant neoplasms

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:dexmedetomidine intravenous infusion

Patients who will receive continuous intraoperative infusion of dexmedetomidine hydrochloride (0.5 µg/kg/h).

Dexmedetomidine intravenous infusion during laparoscopic cholecystecthomy

其他名称:
  • Precedex IV infusion
假比较器:0.9% saline solution intravenous infusion

Patients who will receive continuous infusion of 0.9% saline solution (sham group).

0.9%sodium chloride intravenous infusion during laparoscopic cholecystecthomy

其他名称:
  • 0.9%sodium chloride

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
change in microvascular flow index
大体时间:during surgery

sublingual microvascular density

during surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:EDUARDO TIBIRICA, MD, PhD、National Institute of Cardiology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月1日

初级完成 (实际的)

2025年5月30日

研究完成 (实际的)

2025年8月30日

研究注册日期

首次提交

2021年6月22日

首先提交符合 QC 标准的

2021年6月29日

首次发布 (实际的)

2021年6月30日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CAAE 47593521.1.0000.5279

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅