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Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation

NCT05815056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-18

No results posted yet for this study

Summary

The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:

• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.

Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.

If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.

Conditions

Interventions

DEVICE

Sedakit (R) using hypnosis induced by the virtual reality device

we use the virtual reality device and no medication during the surgery

DRUG

drug intervention

using sufentanyl 5mg intravenously during the surgery

Sponsors & Collaborators

  • Centre Hospitalier Regional de Huy

    lead OTHER

Principal Investigators

  • JeanFrancois Maillart, MD · CHR de Huy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-08-22
Completion
2022-08-25

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815056 on ClinicalTrials.gov