Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)
2026年6月3日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jérôme MASCARELLI, Principal investigator
- 電話番号：+33 4 92 03 29 52
- メール：mascarelli.j@chu-nice.fr
研究場所
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Alpes-Maritimes
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Nice、Alpes-Maritimes、フランス、06000
- CHU de Nice
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コンタクト：
- Charlotte CIAIS, Study coordinator
- 電話番号：+33 04 92 03 93 93
- メール：ciais.c3@chu-nice.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：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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実験的：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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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 |
|---|---|---|
|
Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
時間枠：Intraoperative (from first incision to skin closure)
|
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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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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Operative duration
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bleeding duration ratio
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
|
Intraoperative (from first incision to skin closure)
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Total remifentanil dose
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2026年6月15日
研究の完了 (推定)
2028年3月15日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 26-PP-04
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個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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Inhalation anesthesiaの臨床試験
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