Phase II Study, Randomized, Monocentric, Single-blind, Comparing the Efficacy of Gases Xenon and Desflurane , in Association With a Thoracic Epidural Analgesia in Maintenance Phase of a Colorectal Oncologic Surgery
The first step is divided into 3 parts. 9 patients will be sequentially enrolled (3 patients
in each part).
The patients will be followed during 45 days and the following rules will be used to assess
First part: if no toxicity: initiation of step 2. If 1/3 toxicity : start of the second
part. If 2 or 3/3 toxicity : end of the study Second part: same rules and possible start of
the third part. Third part: if no toxicity: initiation of step 2. If 1 or more toxicity :
end of the study.
The safety will be assessed after each part by an independent data safety monitoring board.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Assess the fluctuation of peroperative mean Arterial Pressure
The initial value (taken just before anesthesia induction) will be compared to the lowest value of mean Arterial Pressure observed during the whole maintenance phase.
during the whole maintenance phase, an expected average of 6 hours
France: Agence Nationale de Sécurité du Médicament et des produits de santé