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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 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

110

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Francja, 06000
        • Chu de Nice
        • Kontakt:
          • Charlotte CIAIS, Study coordinator
          • Numer telefonu: +33 04 92 03 93 93
          • E-mail: ciais.c3@chu-nice.fr

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Inhalation anesthesia
Procedura: 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.
Eksperymentalny: Continuous intravenous anesthesia
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Operative duration
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Bleeding duration ratio
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Centre Hospitalier Universitaire de Nice

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 czerwca 2026

Ukończenie studiów (Szacowany)

15 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 26-PP-04

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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