Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Superficial Venous Insufficiency Clinical Trial

— CIMES  

Official title:

Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228365
• Other study ID #: 2023-A01948-37
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Lauranne MATRAY, MD
• Phone: 05 61 37 81 81
• Email: dr.lmatray.union[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual reality has been shown to reduce the pain experienced during medical procedures. The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Superficial Venous Insufficiency
• Venous Insufficiency

Intervention

Device:
• use of a device incorporating virtual reality software
use of a device incorporating virtual reality software

Drug:
• Neuroleptanalgesia
Usual neuroleptanalgesic treatment

Locations

Country	Name	City	State
France	Clinique de l'Union	Saint-Jean

Sponsors (2)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche	Vivactis M2Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity assessed by NRS (numerical rating scale)	The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable).	Day 1
Secondary	Level of pre-operative anxiety assessed by the patient using the STAI-Y	The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).	Day 0
Secondary	Level of post-operative anxiety assessed by the patient using the STAI-Y	The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory).	Day 1
Secondary	treatment administered during the procedure	Nature and quantities of additional sedative treatment administered during the procedure	Day 1
Secondary	Pain intensity assessed by NRS (numerical rating scale)	Pain intensity assessed by NRS (numerical rating scale)	Day 1
Secondary	Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)	Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).	Day 0
Secondary	Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)	Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied).	Day 1
Secondary	Surgery duration	Assessment of the surgery duration	Day 0
Secondary	Length of stay in the ICU	Length of stay in the ICU	Day 1
Secondary	Length of stay in the hospital	Length of stay in the hospital	Day 1
Secondary	Resumption of current activities	Resumption of current activities measured by: YES or NO	Day 1