Two anesthesia methods to keep the joint clear during shoulder arthroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind study compares two general anesthesia maintenance strategies—sevoflurane inhalation and propofol-based IV anesthesia—to determine which provides better intraoperative visibility during arthroscopic rotator cuff repair. The outcome relates to bleeding within the joint and visibility for the surgeon, with patients in the beach-chair position and receiving an interscalene block. Eligible adults with rotator cuff repair planned, without contraindications to the study drugs, will be randomized to one of the two anesthesia approaches. The trial is conducted at CHU de Nice and is designed to inform anesthesia choices that may impact surgical safety and efficiency.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Nice
  Nice, Alpes-Maritimes, France Recruiting

Study contacts

• Study coordinator: Jérôme MASCARELLI, Principal investigator
• Email: mascarelli.j@chu-nice.fr
• Phone: +33 4 92 03 29 52

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.