Xenon Combined With Intraoperative Thoracic Epidural Analgesia

Colorectal Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT01696630
• Study type: Interventional
• Source: Centre Leon Berard
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Completion date: July 2014