Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial (CLEAR-SHOULDER)
3 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
110
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jérôme MASCARELLI, Principal investigator
- Número de telefone: +33 4 92 03 29 52
- E-mail: mascarelli.j@chu-nice.fr
Locais de estudo
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Alpes-Maritimes
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Nice, Alpes-Maritimes, França, 06000
- Chu de Nice
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Contato:
- Charlotte CIAIS, Study coordinator
- Número de telefone: +33 04 92 03 93 93
- E-mail: ciais.c3@chu-nice.fr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intraoperative surgical field visibility assessed by the modified Fromme-Boezaart score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Operative duration
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Bleeding duration ratio
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de junho de 2026
Conclusão Primária (Estimado)
15 de junho de 2026
Conclusão do estudo (Estimado)
15 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-PP-04
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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