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NCT Number: NCT07628244

Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial

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.

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Key information

Conditions

Rotator Cuff Injuries Anesthesia, General Arthroscopy Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location status: Recruiting

Location contact

Charlotte CIAIS, Study coordinator

CONTACT

[email protected]

04 92 03 93 93 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inhalation anesthesia

Procedure

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.

Continuous intravenous anesthesia

Procedure

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.

Primary outcomes

  1. Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score

    Time frame: 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.

Secondary outcomes

  1. Operative duration

    Time frame: Intraoperative (from first incision to skin closure)

    .Duration of surgery in minutes, measured from first incision to skin closure.

Other outcomes

  1. Bleeding duration ratio

    Time frame: 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.

  2. Proportion of procedures with clinically impaired or difficult visibility

    Time frame: 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.

  3. Total irrigation fluid consumption

    Time frame: 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).

  4. Mean intraoperative arterial pressure

    Time frame: 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.

  5. Number of hypotensive episodes

    Time frame: Intraoperative (from first incision to skin closure)

    Number of episodes of intraoperative hypotension, defined as a mean arterial pressure below 65 mmHg.

  6. Cumulative duration of hypotensive episodes

    Time frame: Intraoperative (from first incision to skin closure)

    Total cumulative duration in minutes of intraoperative periods during which mean arterial pressure was below 65 mmHg.

  7. Total norepinephrine dose

    Time frame: 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).

  8. Total remifentanil dose

    Time frame: Intraoperative (from first incision to skin closure)

    Total cumulative dose of remifentanil administered during the procedure in micrograms.

  9. Surgeon satisfaction with intraoperative visibility

    Time frame: 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.

  10. Intraoperative and immediate postoperative adverse events

    Time frame: 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).

  11. Environmental impact of anesthetic strategy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme MASCARELLI, Principal investigator

CONTACT

[email protected]

+33 4 92 03 29 52

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: CLEAR-SHOULDER

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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