Xenon Combined With Intraoperative Thoracic Epidural Analgesia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|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|
- Variation of intraoperative Mean Arterial Pressure (MAP) [ Time Frame: Maintenance phase ]Variation between the Mean Arterial Pressure (MAP) at induction and the mean of intraoperative MAP values in each patient and comparaison between arms.
- Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP) [ Time Frame: Throughout the maintenance of anesthesia, an expected average of 6 hours ]monitoring device (automatic recorder)
- Delay from the surgery to the discharge date [ Time Frame: from the surgery to the hospital discharge date ]Delay from the date of surgery to the date of hospital discharge (days)
- 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 ]Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
- 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 [ Time Frame: Throughout the maintenance of anesthesia, an expected average of 6 hours ]Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)
- Quality of awaking [ Time Frame: 5 minutes after eyes opening ]Modified Aldrete score and Recovery Index
- Delay to oral feeding recovery [ Time Frame: From surgery to oral feeding reintroduction ]Time from the date of surgery to the date of first subsequent oral food intake
- Post-operative Adverse Events [ Time Frame: 45 days after surgery ]Post-operative Adverse Events (according to the NCI-CTC version 4.03)
- post-operative pain [ Time Frame: At entrance and exit of post operative room and 24 hours after the end of anesthesia ]Score to Visual Analog Scale
- Delay to intestinal transit recovery [ Time Frame: Time to postoperative stools ]Time from the date of surgery to the date of first postoperative stools
|Study Start Date:||October 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Desflurane
Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696630
|Centre Léon Bérard|
|LYON Cedex 08, France, 69373|