Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters
Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Local Anesthesia
Intervention: Remifentanil (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s):
Jean RUIZ, MD, PhD, Principal Investigator, Affiliation: CHU Toulouse
Overall contact:
Jean RUIZ, MD, PhD, Phone: 05 61 77 97 92, Ext: +33, Email: ruiz.jean@chu-toulouse.fr
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.
Clinical Details
Official title: REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
Secondary outcome: Evaluation of patient's anxiety by the Face Anxiety ScalePatient and physician's satisfaction by a 10-points numeric rating scale Number of adverse events Number of realized punctions
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jean RUIZ, MD, PhD, Phone: 05 61 77 97 92, Ext: +33, Email: ruiz.jean@chu-toulouse.fr
University Hospital of Toulouse, Toulouse 31059, France; Recruiting
Jean RUIZ, MD PhD, Principal Investigator
Béatrice RIU, Md, PhD, Sub-Investigator
Vincent MINVILLE, MD, PhD, Sub-Investigator
Elodie BRUNEL, MD, PhD, Sub-Investigator
Michel OLIVIER, MD, PhD, Sub-Investigator
Additional Information
Starting date: August 2014
Last updated: August 20, 2015
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