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。

Cerebral Desaturation Burden After Interscalene or Suprascapular-Axillary Block for Shoulder Arthroscopy

2026年11月10日 更新者：Muhammed E Aydin、Ataturk University

Comparison of the Effects of Preoperative Interscalene Block and Combined Suprascapular and Axillary Nerve Blocks on Cerebral Desaturation Burden in Patients Undergoing Elective Shoulder Arthroscopy in the Beach-Chair Position Under General Anesthesia: A Prospective Randomized Study

Shoulder arthroscopy is often performed with the patient in an upright beach-chair position. Changes in position and anesthesia may affect blood pressure and oxygen delivery to the brain. This study compares two ultrasound-guided nerve block approaches performed before general anesthesia: interscalene block and combined suprascapular and axillary nerve blocks. Participants will be randomly assigned to one of these approaches. Both groups will receive the same general anesthetic and 20 mL of 0.25% bupivacaine for the assigned block approach. Cerebral oxygen saturation will be monitored continuously using sensors placed on the forehead. The main outcome is the total cerebral desaturation burden, measured as the area below 80% of each participant's baseline cerebral oxygen saturation during monitoring. Other outcomes include the occurrence and duration of desaturation, minimum cerebral oxygen saturation, blood pressure and heart rate events, vasopressor use, and immediate recovery and a Mini-Mental State Examination to assess cognitive functions.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

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。

学习联系方式

  • 姓名：Muhammed Enes Aydin, Associate Professor
  • 电话号码：+905543318289
  • 邮箱：enesmd@msn.com

研究联系人备份

学习地点

  • 土耳其（türkiye）
      • Erzurum、土耳其（türkiye）、25000
        • 招聘中
        • Ataturk University
        • 接触：
          • Muhammed Enes Aydin, principal investigator
          • 电话号码：05543318289
          • 邮箱：enesmd@msn.com
        • 接触：

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 65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:

  • Age 18-65 years
  • ASA physical status I or II
  • Scheduled for elective shoulder arthroscopy under general anesthesia in the beach-chair position
  • Provides written informed consent

Exclusion Criteria:

  • Allergy to local anesthetics
  • Previous cervical spine surgery
  • History of cerebrovascular disease or carotid artery surgery
  • Serious cardiac disease, including advanced heart failure or significant valvular disease
  • Neurological disease, including epilepsy, multiple sclerosis, or Parkinson's disease
  • Dementia or cognitive impairment
  • Coagulopathy or contraindication to peripheral nerve block due to anticoagulant use
  • Pregnancy
  • Body mass index greater than 35 kg/m²
  • Technical or anatomical obstacle to performing the planned nerve block

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：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Interscalene Block (ISB)

Participants will receive a preoperative ultrasound-guided interscalene nerve block using 20 mL of 0.25% bupivacaine.
程序：Ultrasound-Guided Interscalene Nerve Block

A preoperative ultrasound-guided interscalene block will be performed with the patient supine and the head turned to the opposite side. A total of 20 mL of 0.25% bupivacaine will be injected around the brachial plexus roots.
实验性的：Combined Suprascapular and Axillary Nerve Blocks (SSAX)

Participants will receive preoperative ultrasound-guided suprascapular and axillary nerve blocks. A total of 20 mL of 0.25% bupivacaine will be divided between the two blocks.
程序：ltrasound-Guided Combined Suprascapular and Axillary Nerve Blocks

Preoperative ultrasound-guided suprascapular and axillary nerve blocks will be performed. A total of 20 mL of 0.25% bupivacaine will be divided between the two block sites.

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
Total Cerebral Desaturation Burden (AUC)
大体时间：From baseline measurement before the nerve block until 10 minutes after return to the supine position.

The area under the curve below the desaturation threshold, defined as 80% of baseline regional cerebral oxygen saturation (rSO₂). AUC will be calculated separately for each hemisphere; the mean of the two hemispheres will be used for the primary comparison. Only desaturation episodes lasting at least 15 seconds will be included. The unit is %·min.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.

次要结果测量

结果测量
措施说明
大体时间
Incidence and Number of Cerebral Desaturation Events
大体时间：From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Proportion of participants with, and number of, cerebral desaturation events, defined as a decrease in rSO₂ of at least 20% from baseline lasting at least 15 seconds.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Total Time Below the Cerebral Desaturation Threshold
大体时间：From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Total time during which rSO₂ remains below 80% of baseline.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Minimum Right and Left Cerebral rSO₂
大体时间：From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Minimum rSO₂ values recorded from the right and left frontal hemispheres; values will be assessed separately.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Ipsilateral and Contralateral Cerebral Desaturation Burden
大体时间：From baseline measurement before the nerve block until 10 minutes after return to the supine position.

AUC below the desaturation threshold in the cerebral hemisphere ipsilateral and contralateral to the operated shoulder.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Incidence of Intraoperative Hypotension and Bradycardia
大体时间：During the intraoperative period.

Proportion of participants with hypotension, defined as a decrease in baseline systolic blood pressure of more than 20% or MAP below 65 mmHg, and bradycardia, defined as heart rate below 50 beats/min.
During the intraoperative period.
Total Intraoperative Ephedrine and Norepinephrine Dose
大体时间：During the intraoperative period.

Total ephedrine dose in mg and total norepinephrine dose in µg administered intraoperatively.
During the intraoperative period.
Post-Anesthesia Care Unit Length of Stay
大体时间：Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).

Time elapsed, in minutes, from postoperative admission to the post-anesthesia care unit to discharge to the surgical ward. Patients are discharged when the Modified Aldrete Score reaches 9 or higher.
Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).
Modified Aldrete Score at Post-Anesthesia Care Unit Discharge
大体时间：Perioperative period (at discharge from the post-anesthesia care unit).

The Modified Aldrete Score is recorded at discharge from the post-anesthesia care unit to the surgical ward. The scale assesses activity, respiration, circulation, consciousness, and oxygen saturation. Each component is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate better physiological recovery from anesthesia. Patients are discharged when the total score reaches 9 or higher.
Perioperative period (at discharge from the post-anesthesia care unit).
Assessment of cognitive functions at the 24th postoperative hour
大体时间：At the 24th postoperative hour

A Mini-Mental State Examination was performed at the 24th postoperative hour to assess cognitive functions.
At the 24th postoperative hour

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。

赞助

Ataturk University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2026年11月10日

初级完成 (估计的)

2026年12月29日

研究完成 (估计的)

2026年12月29日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • B.30.2.ATA.0.01.00/144
  • 2026/5 (其他标识符：Atatürk University Clinical Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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