Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters
REMIDOLCATH
REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 29, 2020
July 1, 2020
3.3 years
March 10, 2014
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
up to 60 minutes
Secondary Outcomes (4)
Evaluation of patient's anxiety by the Face Anxiety Scale
up to 60 minutes
Patient and physician's satisfaction by a 10-points numeric rating scale
up to 60 minutes
Number of adverse events
up to 60 minutes
Number of realized punctions
up to 60 minutes
Study Arms (2)
Remifentanil
EXPERIMENTALPatients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion
Placebo
PLACEBO COMPARATORPatients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion
Interventions
Eligibility Criteria
You may qualify if:
- more than 18 years old
- eligible for CVC insertion
You may not qualify if:
- pregnancy
- patients who can't give their consent
- contra-indications to remifentanil infusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Toulouse
Toulouse, 31059, France
Related Publications (1)
Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
PMID: 31094935RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean RUIZ, MD, PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2014
First Posted
August 1, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share