Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jérôme MASCARELLI, Principal investigator
- Número de teléfono: +33 4 92 03 29 52
- Correo electrónico: mascarelli.j@chu-nice.fr
Ubicaciones de estudio
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Francia, 06000
- CHU de Nice
-
Contacto:
- Charlotte CIAIS, Study coordinator
- Número de teléfono: +33 04 92 03 93 93
- Correo electrónico: ciais.c3@chu-nice.fr
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Operative duration
Periodo de tiempo: 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)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bleeding duration ratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
15 de junio de 2026
Finalización del estudio (Estimado)
15 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-PP-04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .