Xenon Combined With Intraoperative Thoracic Epidural Analgesia

Léon Bérard Center

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Desflurane

Drug: Xenon

Study type

Interventional

Funder types

Other

Identifiers

NCT01696630

ET2012-19 (Other Identifier)

2012-002155-41 (EudraCT Number)

XENON

Details and patient eligibility

About

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.

Full description

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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