This is a monocentric study in 2 steps: A safety part to assess the feasibility of using Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled and followed over 45 days.
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 the safety: First part: if no toxicity: initiation of the randomised part. 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 the randomised part. If 1 or more toxicity: end of the study. The safety will be assessed after each part by an independent data safety monitoring board.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
31
Centre Léon Bérard
Lyon, France
Variation of intraoperative Mean Arterial Pressure (MAP)
Variation between the Mean Arterial Pressure (MAP) at induction and the mean of intraoperative MAP values in each patient and comparaison between arms.
Time frame: Maintenance phase
Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)
monitoring device (automatic recorder)
Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours
Delay from the surgery to the discharge date
Delay from the date of surgery to the date of hospital discharge (days)
Time frame: from the surgery to the hospital discharge date
Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
Time frame: from the end of surgery up to Post Anesthesia Care Unit's exit
Total dose requirement of Vasopressive and hypotensive agents
Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours
Volume of each product infused
Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours
Total dose of morphine
Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)
Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours
Quality of awaking
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Modified Aldrete score and Recovery Index
Time frame: 5 minutes after eyes opening
Delay to oral feeding recovery
Time from the date of surgery to the date of first subsequent oral food intake
Time frame: From surgery to oral feeding reintroduction
Post-operative Adverse Events
Post-operative Adverse Events (according to the NCI-CTC version 4.03)
Time frame: 45 days after surgery
post-operative pain
Score to Visual Analog Scale
Time frame: At entrance and exit of post operative room and 24 hours after the end of anesthesia
Delay to intestinal transit recovery
Time from the date of surgery to the date of first postoperative stools
Time frame: Time to postoperative stools