Status:
COMPLETED
Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Anesthesia, Epidural
Paraesthesia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia. Primary Endpoint: I...
Detailed Description
Epidural anaesthesia is a central neuraxial block technique with many applications. Improvements in equipment, drugs and technique have made it a popular and versatile anaesthetic technique, with appl...
Eligibility Criteria
Inclusion
- Patients scheduled for thoracic epidural anaesthesia (TEA), with or without general anaesthesia.
- American Society of Anesthesiologists (ASA) class I-III
- Patients aged 18 and ≤ 75 years of age
Exclusion
- Anamnestic exclusion criteria are all contraindications for epidural anaesthesia.
- Severe scoliosis, previous surgery on the spine, M. Bechterew disease
- Non-competent and non-cooperative patients
- Patients with medicament and drug abuse problems, problems in communication, participating in parallel in another clinical study with experimental drugs or devices, receiving prohibited concomitant therapies
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00394459
Start Date
April 1 2005
End Date
May 1 2009
Last Update
May 13 2011
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ