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

19 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

110

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrijk, 06000
        • Werving
        • Chu De Nice
        • Contact:
          • Charlotte CIAIS, Study coordinator
          • Telefoonnummer: +33 04 92 03 93 93
          • E-mail: ciais.c3@chu-nice.fr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Inhalation anesthesia
Procedure: 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.
Experimenteel: Continuous intravenous anesthesia
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Operative duration
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bleeding duration ratio
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de Nice

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 juni 2026

Primaire voltooiing (Werkelijk)

18 juni 2026

Studie voltooiing (Geschat)

18 maart 2028

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

19 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-PP-04

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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