Xenon Combined With Intraoperative Thoracic Epidural Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01696630
First received: September 21, 2012
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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.

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 Xenon and Desflurane, in Association With a Thoracic Epidural Analgesia in the Maintenance Phase of a Colorectal Oncologic Surgery

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Variation of intraoperative Mean Arterial Pressure (MAP) [ Time Frame: Maintenance phase ] [ Designated as safety issue: No ]
    Variation between the Mean Arterial Pressure (MAP) at induction and the mean of intraoperative MAP values in each patient and comparaison between arms.


Secondary Outcome Measures:
  • Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP) [ Time Frame: Throughout the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
    monitoring device (automatic recorder)

  • Delay from the surgery to the discharge date [ Time Frame: from the surgery to the hospital discharge date ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Volume of each product infused [ Time Frame: Throughout the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: No ]
  • Total dose of morphine [ Time Frame: Throughout the maintenance of anesthesia, an expected average of 6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Modified Aldrete score and Recovery Index

  • Delay to oral feeding recovery [ Time Frame: From surgery to oral feeding reintroduction ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Score to Visual Analog Scale

  • Delay to intestinal transit recovery [ Time Frame: Time to postoperative stools ] [ Designated as safety issue: No ]
    Time from the date of surgery to the date of first postoperative stools


Enrollment: 31
Study Start Date: October 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
France
Centre Léon Bérard
LYON Cedex 08, France, 69373
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: August 3, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Leon Berard:
anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change

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
Desflurane
Isoflurane
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016