A Study Which Compares the Efficacy of Xenon and Desflurane in Association With a Thoracic Epidural Analgesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01696630
First received: September 21, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

This is a monocentric study in 2 steps. First, there is a safety part to assess the feasibility of using Xenon in association with a thoracic epidural analgesia.

A maximum of 9 patients will be enrolled in this first step. If the association is considered as safe, the second step will be initiated. This part will be randomized, simple blinded with 2 arms. 28 patients will be enrolled and will be followed during 45 days.


Condition Intervention Phase
Colorectal Cancer
Drug: Xenon
Drug: Desflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Gases Xenon and Desflurane , in Association With a Thoracic Epidural Analgesia in Maintenance Phase of a Colorectal Oncologic Surgery

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Assess the fluctuation of peroperative mean Arterial Pressure [ Time Frame: during the whole maintenance phase, an expected average of 6 hours ] [ Designated as safety issue: No ]
    The initial value (taken just before anesthesia induction) will be compared to the lowest value of mean Arterial Pressure observed during the whole maintenance phase.


Secondary Outcome Measures:
  • Measure of Systolic ejection volume [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Assess the number of days including the surgery date and the discharge date [ Designated as safety issue: No ]
  • Assess the number of minutes between the end of surgery and postoperative room exit [ Designated as safety issue: No ]
  • Assess the total dose administered of vasopressive and hypotensive agents [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: No ]
    in mg/Kg

  • Assess the volume of each product administered for hydration [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: No ]
    in mL/Kg/hour

  • Assess the total dose of morphinics [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: No ]
    required to maintain BIS between 40 and 60 (in mg/kg)

  • Assess the Aldrete score and Recovery Index [ Time Frame: 5 minutes after eyes opening ] [ Designated as safety issue: No ]
  • Assess the number of days until an oral feeding [ Designated as safety issue: No ]
  • Patients with Adverse Events as a Measure of Safety [ Time Frame: 45 days after surgery ] [ Designated as safety issue: Yes ]
    according to the NCI-CTC version 4.03

  • Assess the Score to Visual analog scale for pain [ Time Frame: At entrance and exit of post operative room and 24 hours after the end of anesthesia ] [ Designated as safety issue: No ]
  • Measure of corrected ejection time [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Measure of heart rate [ Time Frame: All along the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Assess the delay of bowel movement recovery [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desflurane
Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
Drug: Desflurane
Experimental: Xenon
Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
Drug: Xenon

Detailed 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 step 2. 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 step 2. If 1 or more toxicity : end of the study.

The safety will be assessed after each part by an independent data safety monitoring board.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696630

Contacts
Contact: Julien GAUTIER +33 4 26 55 68 29 julien.gautier@lyon.unicancer.fr
Contact: Valérie FOUILLAT +33 4 78 78 79 39 valerie.fouillat@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
LYON Cedex 08, France, 69373
Principal Investigator: Georges ROMERO, MD         
Sub-Investigator: Edouard AUBERT, MD         
Sub-Investigator: Patrick BACHMANN, MD         
Sub-Investigator: Henri-Jacques CLEMENT, MD         
Sub-Investigator: Anne-Laure DAUNIZEAU-WALKER, MD         
Sub-Investigator: Baptiste VALLEIX, MD         
Sub-Investigator: Jean-Edgard MAZERES, MD         
Sub-Investigator: Fabienne MONTANGE, MD         
Sub-Investigator: Véronique PERES-BACHELOT, MD         
Sub-Investigator: Stéphanie POUDEROUX-MARTIN, MD         
Sub-Investigator: Hervé ROSAY, MD         
Sub-Investigator: Henri SEBBAN, MD         
Sponsors and Collaborators
Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01696630     History of Changes
Other Study ID Numbers: XENON, 2012-002155-41, ET2012-19
Study First Received: September 21, 2012
Last Updated: May 16, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Leon Berard:
maintenance of anesthesia

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Xenon
Desflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014