Xenon Combined With Intraoperative Thoracic Epidural Analgesia

Phase II Study, Randomized, Monocentric, Single-blind, Comparing the Efficacy of Xenon and Desflurane, in Association With a Thoracic Epidural Analgesia in the Maintenance Phase of a Colorectal Oncologic Surgery

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.

Inclusion Criteria:

• Older than 18 years old
• Planned surgery for oncologic colic and/or rectal surgery
• ASA score I or II
• Indication of complementary thoracic epidural analgesia
• Agree to use an effective form of contraception
• Patients who can understand, read and write French language
• Covered by a medical insurance
• Patients who have dated/signed an inform consent

Exclusion Criteria:

• Unstable angina within the 30 last days
• Myocardial infarction within 28 days prior to surgery
• Uncontrolled arterial high blood pressure
• Severe cardiac insufficiency
• Severe chronic obstructive pneumopathy
• Patient who requires FiO2 > 40%
• Patient already enrolled in a clinical study which may interfere with the present study
• Known hypersensitivity to one of the study drugs
• History or familial history of malignant hyperthermia
• Documented high intracranial pressure
• Eclampsia or pre-eclampsia
• Pregnant or breastfeeding woman
• Liver injury (icterus) and/or unexplained fever and/or eosinophilia after halogen exposure
• Failure in epidural anesthesia installation
• Patient refusal
• Patient who can't be compliant to the present protocol