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临床试验/NCT07628244
NCT07628244招募中不适用

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

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年6月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Inhalation anesthesia

Active Comparator

干预措施: Inhalation anesthesia (Procedure)

Continuous intravenous anesthesia

Experimental

干预措施: Continuous intravenous anesthesia (Procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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