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Effect of Dexamethason on Postimplantation Syndrome After EVAR
Sponsor: Centro Hospitalar de Lisboa Central
Summary
This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Participating researchers must be vascular surgeons or vascular anesthesiologists certified by national entities. Recruitment is expected to begin in the second semester of 2023. The trial will follow the ICH-GCP guidelines and national and international legislation and reporting will be performed according to CONSORT 2010 guidelines. Site inclusion requires hospital ethics committee approval. Written informed consent is mandatory for all patients and the information and consent forms must be approved by Institutional Ethics Committee.
Official title: The Effect of Preoperative Dexamethasone on Postimplantation Syndrome After Endovascular Aneurysm Repair - Protocol for a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2023-11-01
Completion Date
2026-05-31
Last Updated
2023-09-21
Healthy Volunteers
No
Interventions
Dexamethasone
Administration of a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.
Placebo
Administration of the same amount of saline solution instead of dexamethasone