Xenon Combined With Intraoperative Thoracic Epidural Analgesia

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Treatments: Desflurane; Isoflurane; Xenon

Criteria

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