Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)
2026년 6월 3일 업데이트: Centre Hospitalier Universitaire de Nice
Shoulder arthroscopy is one of the most common orthopedic procedures, and the quality of the surgeon's view inside the joint is critical to its safety and success. Unlike limb surgery, no tourniquet can be applied to the shoulder, so surgical visibility depends almost entirely on how much bleeding occurs within the joint - which is itself influenced by the anesthetic drugs used to keep the patient asleep.
Two standard techniques exist for maintaining general anesthesia: inhaled anesthesia (sevoflurane) and total intravenous anesthesia (TIVA, using propofol). Evidence from other types of keyhole surgery (nasal, ear) suggests that propofol may produce better surgical visibility, possibly because sevoflurane causes slightly greater dilation of the smallest blood vessels in tissue, leading to more bleeding into the joint. However, in shoulder arthroscopy specifically, the data are scarce and contradictory.
CLEAR-SHOULDER is a randomized, single-blind trial designed to determine whether propofol-based intravenous anesthesia provides superior intraoperative visibility compared to sevoflurane-based inhaled anesthesia during arthroscopic rotator cuff repair. Surgical visibility will be assessed from blinded video recordings of each procedure using the validated modified Fromme-Boezaart score. An exploratory artificial intelligence analysis of the arthroscopic videos will also be conducted.
Secondary outcomes include operating time, irrigation fluid consumption, hemodynamic stability, vasopressor requirements, surgeon satisfaction, postoperative recovery, and environmental impact of each anesthetic strategy.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
110
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jérôme MASCARELLI, Principal investigator
- 전화번호: +33 4 92 03 29 52
- 이메일: mascarelli.j@chu-nice.fr
연구 장소
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Alpes-Maritimes
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Nice, Alpes-Maritimes, 프랑스, 06000
- CHU de Nice
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연락하다:
- Charlotte CIAIS, Study coordinator
- 전화번호: +33 04 92 03 93 93
- 이메일: ciais.c3@chu-nice.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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아니
설명
Inclusion Criteria:
- Patient aged 18 or over
- Patient scheduled for elective rotator cuff repair arthroscopy (RCRA), performed in the "beach-chair" position under general anesthesia combined with an interscalene block (with or without standard associated procedures such as acromioplasty and/or tenotomy/tenodesis of the long biceps). Procedures for instability (Bankart/Latarjet), fractures, capsulitis, simple lavage, or any arthroscopy not focused on rotator cuff repair (RCR) are not eligible.
- Patient with an ASA score of I to IV
- Patient affiliated to a social security scheme,
- Patient having given written consent following written and oral information.
Exclusion Criteria:
- Patients with a contraindication to any of the study agents, including known hypersensitivity or allergy to any of these agents or to any of their excipients.
- Patients with known coagulopathy (abnormal PT/INR; platelets < 100,000/L) or
- Patients with active preoperative hemarthrosis or local infection.
- Non-elective (emergency) surgery or a procedure whose initial objective is not rotator cuff repair arthroscopy (RCRA). Note: Intraoperative conversion to open surgery is not an exclusion criterion; it will be considered an intraoperative event and managed in the analysis according to the intention-to-treat (ITT) principle, with a sensitivity analysis procedure described in the statistical plan.
- Uncooperative patient, inability to consent
- Pregnant women
- Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article L. 1121-16 of the French Public Health Code.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Inhalation anesthesia
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Inhaled anesthesia maintenance with sevoflurane, titrated to maintain a Bispectral Index (BIS) between 40 and 60 throughout the procedure.
Analgesia maintained with remifentanil target-controlled infusion (TCI) at 4 ng/mL cerebral target.
Induction performed with propofol, atracurium, ketamine and dexamethasone.
Norepinephrine administered as needed to maintain mean arterial pressure ≥ 70 mmHg.
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실험적: Continuous intravenous anesthesia
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Total intravenous anesthesia (TIVA) maintenance with propofol target-controlled infusion (TCI, Schnider model), titrated to maintain a Bispectral Index (BIS) between 40 and 60 throughout the procedure.
Analgesia maintained with remifentanil target-controlled infusion (TCI) at 4 ng/mL cerebral target.
Induction performed with propofol TCI (4-6 ng/mL cerebral target), atracurium, ketamine and dexamethasone.
Norepinephrine administered as needed to maintain mean arterial pressure ≥ 70 mmHg.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
기간: Intraoperative (from first incision to skin closure)
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Time-weighted mean modified Fromme-Boezaart score assessed over the entire surgical procedure by two independent blinded evaluators analyzing standardized arthroscopic video segments.
The modified Fromme-Boezaart scale ranges from 0 (no bleeding, perfect visibility) to 5 (severe bleeding, surgery impossible).
Higher scores indicate worse surgical visibility.
In case of discordance greater than 1 point between the two evaluators, a third independent evaluator will adjudicate.
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Intraoperative (from first incision to skin closure)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Operative duration
기간: Intraoperative (from first incision to skin closure)
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.Duration of surgery in minutes, measured from first incision to skin closure.
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Intraoperative (from first incision to skin closure)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bleeding duration ratio
기간: Intraoperative (from first incision to skin closure)
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Ratio of total bleeding duration to total operative duration.
Bleeding duration is defined as the cumulative duration of arthroscopic video segments with a modified Fromme-Boezaart score ≥ 3.
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Intraoperative (from first incision to skin closure)
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Proportion of procedures with clinically impaired or difficult visibility
기간: Intraoperative (from first incision to skin closure)
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Proportion of patients with clinically impaired visibility, defined as ≥ 20% of video segments scoring ≥ 3 on the modified Fromme-Boezaart scale; and proportion with difficult visibility, defined as ≥ 20% of segments scoring ≥ 4.
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Intraoperative (from first incision to skin closure)
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Total irrigation fluid consumption
기간: Intraoperative (from first incision to skin closure)
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Total volume of irrigation fluid used during the procedure, recorded in milliliters at the end of the intervention before patient transfer to the post-anesthesia care unit (PACU).
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Intraoperative (from first incision to skin closure)
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Mean intraoperative arterial pressure
기간: Intraoperative (from first incision to skin closure)
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Mean arterial pressure (MAP) measured every 3 minutes throughout the procedure using a non-invasive blood pressure cuff.
A corrected cerebral MAP will also be estimated based on the height difference between the measurement site and the external auditory meatus.
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Intraoperative (from first incision to skin closure)
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Number of hypotensive episodes
기간: Intraoperative (from first incision to skin closure)
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Number of episodes of intraoperative hypotension, defined as a mean arterial pressure below 65 mmHg.
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Intraoperative (from first incision to skin closure)
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Cumulative duration of hypotensive episodes
기간: Intraoperative (from first incision to skin closure)
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Total cumulative duration in minutes of intraoperative periods during which mean arterial pressure was below 65 mmHg.
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Intraoperative (from first incision to skin closure)
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Total norepinephrine dose
기간: Intraoperative (from first incision to skin closure)
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Total cumulative dose of norepinephrine administered during the procedure in micrograms, regardless of administration route (intravenous bolus or continuous infusion).
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Intraoperative (from first incision to skin closure)
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Total remifentanil dose
기간: Intraoperative (from first incision to skin closure)
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Total cumulative dose of remifentanil administered during the procedure in micrograms.
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Intraoperative (from first incision to skin closure)
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Surgeon satisfaction with intraoperative visibility
기간: Immediately after surgery (before patient leaves the operating room)
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Surgeon self-assessed satisfaction with intraoperative surgical visibility, rated on a 10-point Likert scale (1 = very unsatisfactory; 10 = very satisfactory), completed immediately at the end of the procedure.
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Immediately after surgery (before patient leaves the operating room)
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Intraoperative and immediate postoperative adverse events
기간: From entry into the operating room to PACU discharge (approximately 1 to 2 hours postoperatively)
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Number and type of adverse events occurring from entry into the operating room to discharge from the post-anesthesia care unit (PACU), including emergence disorders (agitation, delayed awakening, confusion, prolonged somnolence, emergence delirium assessed by RASS and NuDESC scales), postoperative nausea and vomiting, and cardiac rhythm disorders (bradycardia or tachycardia).
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From entry into the operating room to PACU discharge (approximately 1 to 2 hours postoperatively)
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Environmental impact of anesthetic strategy
기간: Intraoperative (from first incision to skin closure)
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Exploratory estimation of the carbon footprint (CO2 equivalent) of each anesthetic strategy, based on recorded consumption of sevoflurane (mL, fresh gas flow parameters) in the inhaled anesthesia group and propofol (mg) in the TIVA group, using published conversion factors from the literature.
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Intraoperative (from first incision to skin closure)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2026년 6월 15일
연구 완료 (추정된)
2028년 3월 15일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 3일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 3일
마지막으로 확인됨
2026년 5월 1일
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