Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)
3 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
110
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jérôme MASCARELLI, Principal investigator
- Numero di telefono: +33 4 92 03 29 52
- Email: mascarelli.j@chu-nice.fr
Luoghi di studio
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 06000
- Chu de Nice
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Contatto:
- Charlotte CIAIS, Study coordinator
- Numero di telefono: +33 04 92 03 93 93
- Email: ciais.c3@chu-nice.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Operative duration
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Bleeding duration ratio
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 giugno 2026
Completamento primario (Stimato)
15 giugno 2026
Completamento dello studio (Stimato)
15 marzo 2028
Date di iscrizione allo studio
Primo inviato
29 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 giugno 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-PP-04
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Lesioni della cuffia dei rotatori
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