Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation (CIMES)

November 25, 2025 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Jean, France, 31240
      • Villeneuve-d'Ascq, France, 59650
        • Recruiting
        • Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: usual neuroleptanalgesic treatment
- Group 1: local anaesthesia by tumescence + neuroleptanalgesia
Drug: Neuroleptanalgesia
Usual neuroleptanalgesic treatment
Experimental: use of a device incorporating virtual reality software
- Group 2: local anaesthesia by tumescence with virtual reality software
Device: use of a device incorporating virtual reality software
use of a device incorporating virtual reality software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity assessed by NRS (numerical rating scale)
Time Frame: Day 1
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Vivactis M2Research

Investigators

  • Principal Investigator: Lauranne MATRAY, MD, Clinique de l'Union

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01948-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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