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Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)

3. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

110

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankreich, 06000
        • CHU de Nice
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Patient aged 18 or over
  2. 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.
  3. Patient with an ASA score of I to IV
  4. Patient affiliated to a social security scheme,
  5. Patient having given written consent following written and oral information.

Exclusion Criteria:

  1. 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.
  2. Patients with known coagulopathy (abnormal PT/INR; platelets < 100,000/L) or
  3. Patients with active preoperative hemarthrosis or local infection.
  4. 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.
  5. Uncooperative patient, inability to consent
  6. Pregnant women
  7. 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Inhalation anesthesia
Verfahren: Inhalation anesthesia
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.
Experimental: Continuous intravenous anesthesia
Verfahren: Continuous intravenous anesthesia
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Zeitfenster: 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.
Intraoperative (from first incision to skin closure)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Operative duration
Zeitfenster: Intraoperative (from first incision to skin closure)
.Duration of surgery in minutes, measured from first incision to skin closure.
Intraoperative (from first incision to skin closure)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bleeding duration ratio
Zeitfenster: Intraoperative (from first incision to skin closure)
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.
Intraoperative (from first incision to skin closure)
Proportion of procedures with clinically impaired or difficult visibility
Zeitfenster: Intraoperative (from first incision to skin closure)
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.
Intraoperative (from first incision to skin closure)
Total irrigation fluid consumption
Zeitfenster: Intraoperative (from first incision to skin closure)
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).
Intraoperative (from first incision to skin closure)
Mean intraoperative arterial pressure
Zeitfenster: Intraoperative (from first incision to skin closure)
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.
Intraoperative (from first incision to skin closure)
Number of hypotensive episodes
Zeitfenster: Intraoperative (from first incision to skin closure)
Number of episodes of intraoperative hypotension, defined as a mean arterial pressure below 65 mmHg.
Intraoperative (from first incision to skin closure)
Cumulative duration of hypotensive episodes
Zeitfenster: Intraoperative (from first incision to skin closure)
Total cumulative duration in minutes of intraoperative periods during which mean arterial pressure was below 65 mmHg.
Intraoperative (from first incision to skin closure)
Total norepinephrine dose
Zeitfenster: Intraoperative (from first incision to skin closure)
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)
Total remifentanil dose
Zeitfenster: Intraoperative (from first incision to skin closure)
Total cumulative dose of remifentanil administered during the procedure in micrograms.
Intraoperative (from first incision to skin closure)
Surgeon satisfaction with intraoperative visibility
Zeitfenster: Immediately after surgery (before patient leaves the operating room)
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.
Immediately after surgery (before patient leaves the operating room)
Intraoperative and immediate postoperative adverse events
Zeitfenster: From entry into the operating room to PACU discharge (approximately 1 to 2 hours postoperatively)
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).
From entry into the operating room to PACU discharge (approximately 1 to 2 hours postoperatively)
Environmental impact of anesthetic strategy
Zeitfenster: Intraoperative (from first incision to skin closure)
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.
Intraoperative (from first incision to skin closure)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Hospitalier Universitaire de Nice

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

15. Juni 2026

Studienabschluss (Geschätzt)

15. März 2028

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-PP-04

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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