Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Nice
RECRUITING
Nice
Contact Information
Primary
Jérôme MASCARELLI, Principal investigator
mascarelli.j@chu-nice.fr
+33 4 92 03 29 52
Time Frame
Start Date: 2026-06-18
Estimated Completion Date: 2028-03-18
Participants
Target number of participants: 110
Treatments
Active_comparator: Inhalation anesthesia
Experimental: Continuous intravenous anesthesia
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov