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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Muhammed Enes Aydin, Associate Professor
- 전화번호: +905543318289
- 이메일: enesmd@msn.com
연구 연락처 백업
- 이름: Emir Sahan, assistant doctor
- 전화번호: +905332773733
- 이메일: Emirsahan94@gmail.com
연구 장소
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Erzurum, 터키 (Türkiye), 25000
- 모병
- Ataturk University
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연락하다:
- Muhammed Enes Aydin, principal investigator
- 전화번호: 05543318289
- 이메일: enesmd@msn.com
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연락하다:
- Emir Sahan, assistant doctor
- 전화번호: +90-533-277-37-33
- 이메일: Emirsahan94@gmail.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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활성 비교기: 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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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Cerebral Desaturation Burden (AUC)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence and Number of Cerebral Desaturation Events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
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연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- B.30.2.ATA.0.01.00/144
- 2026/5 (기타 식별자: Atatürk University Clinical Research Ethics Committee)
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