Search / Trial NCT06228365

Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Jan 26, 2024

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Description

The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure. Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients. Maximum duration of patient participation in the study = 2 days.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).
  • * Outpatients with superficial venous insufficiency for which a surgical indication has been given
  • * Patient requiring sedation associated with local anesthesia
  • Exclusion Criteria:
  • * Contraindication to local anesthesia or any of the sedatives used in the protocol
  • * Hearing or visual impairment contraindicating use of the virtual reality headset
  • * Pregnant or breast-feeding patients
  • * Unbalanced epilepsy
  • * Patients under court protection, guardianship or curatorship
  • * Patients not affiliated to the French social security system
  • * Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Saint Jean, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0