Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters (REMIDOLCATH)

July 28, 2020 updated by: University Hospital, Toulouse

REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS

At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital of Toulouse

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more than 18 years old
  • eligible for CVC insertion

Exclusion Criteria:

  • pregnancy
  • patients who can't give their consent
  • contra-indications to remifentanil infusion

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remifentanil
Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion
Drug: Remifentanil
Pain's evaluation for Remifentanil Group
Placebo Comparator: Placebo
Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion
Drug: Placebo
CVC pain's evaluation after local anesthesia + placebo infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
Time Frame: up to 60 minutes
up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of patient's anxiety by the Face Anxiety Scale
Time Frame: up to 60 minutes
up to 60 minutes
Patient and physician's satisfaction by a 10-points numeric rating scale
Time Frame: up to 60 minutes
up to 60 minutes
Number of adverse events
Time Frame: up to 60 minutes
up to 60 minutes
Number of realized punctions
Time Frame: up to 60 minutes
up to 60 minutes

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Jean RUIZ, MD, PhD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 6932 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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