Cerebral Desaturation Burden After Interscalene or Suprascapular-Axillary Block for Shoulder Arthroscopy
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muhammed Enes Aydin, Associate Professor
- 電話番号：+905543318289
- メール：enesmd@msn.com
研究連絡先のバックアップ
- 名前：Emir Sahan, assistant doctor
- 電話番号：+905332773733
- メール：Emirsahan94@gmail.com
研究場所
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Erzurum、トルコ（Türkiye）、25000
- 募集
- Ataturk University
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コンタクト：
- Muhammed Enes Aydin, principal investigator
- 電話番号：05543318289
- メール：enesmd@msn.com
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コンタクト：
- Emir Sahan, assistant doctor
- 電話番号：+90-533-277-37-33
- メール：Emirsahan94@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Interscalene Block (ISB)
Participants will receive a preoperative ultrasound-guided interscalene nerve block using 20 mL of 0.25% bupivacaine. |
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. |
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実験的：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Cerebral Desaturation Burden (AUC)
時間枠：From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence and Number of Cerebral Desaturation Events
時間枠：From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Total Time Below the Cerebral Desaturation Threshold
時間枠：From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Minimum Right and Left Cerebral rSO₂
時間枠：From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Ipsilateral and Contralateral Cerebral Desaturation Burden
時間枠：From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Incidence of Intraoperative Hypotension and Bradycardia
時間枠：During the intraoperative period.
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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.
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Total Intraoperative Ephedrine and Norepinephrine Dose
時間枠：During the intraoperative period.
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Total ephedrine dose in mg and total norepinephrine dose in µg administered intraoperatively. |
During the intraoperative period.
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Post-Anesthesia Care Unit Length of Stay
時間枠：Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).
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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).
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Modified Aldrete Score at Post-Anesthesia Care Unit Discharge
時間枠：Perioperative period (at discharge from the post-anesthesia care unit).
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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).
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Assessment of cognitive functions at the 24th postoperative hour
時間枠：At the 24th postoperative hour
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A Mini-Mental State Examination was performed at the 24th postoperative hour to assess cognitive functions. |
At the 24th postoperative hour
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
- Thanaboriboon C, Vanichvithya P, Jinaworn P. What Is the Risk of Intraoperative Cerebral Oxygen Desaturation in Patients Undergoing Shoulder Surgery in the Beach Chair Position? Clin Orthop Relat Res. 2021 Dec 1;479(12):2677-2687. doi: 10.1097/CORR.0000000000001864.
- Harsanji Drenjancevic I, Drenjancevic D, Davidovic-Cvetko E, Drenjancevic I, Gulam D, Kvolik S. DOES THE ANESTHESIA TECHNIQUE AFFECT ARTERIAL PRESSURE AND REGIONAL CEREBRAL OXYGEN SATURATION DURING SHOULDER ARTHROSCOPY IN THE BEACH CHAIR POSITION? Acta Clin Croat. 2018 Sep;57(3):473-479. doi: 10.20471/acc.2018.57.03.10.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- B.30.2.ATA.0.01.00/144
- 2026/5 (その他の識別子：Atatürk University Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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