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Xenon Combined With Intraoperative Thoracic Epidural Analgesia

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Xenon
Desflurane
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Léon Bérard

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Desflurane

Xenon

Arm Description

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

Outcomes

Primary Outcome Measures

Variation of intraoperative Mean Arterial Pressure (MAP)
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)
monitoring device (automatic recorder)
Delay from the surgery to the 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)
Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
Total dose requirement of Vasopressive and hypotensive agents
Volume of each product infused
Total dose of morphine
Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)
Quality of awaking
Modified Aldrete score and Recovery Index
Delay to oral feeding recovery
Time from the date of surgery to the date of first subsequent oral food intake
Post-operative Adverse Events
Post-operative Adverse Events (according to the NCI-CTC version 4.03)
post-operative pain
Score to Visual Analog Scale
Delay to intestinal transit recovery
Time from the date of surgery to the date of first postoperative stools

Full Information

First Posted
September 21, 2012
Last Updated
August 3, 2016
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT01696630
Brief Title
Xenon Combined With Intraoperative Thoracic Epidural Analgesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
Arm Title
Xenon
Arm Type
Experimental
Arm Description
Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Type
Drug
Intervention Name(s)
Desflurane
Primary Outcome Measure Information:
Title
Variation of intraoperative Mean Arterial Pressure (MAP)
Description
Variation between the Mean Arterial Pressure (MAP) at induction and the mean of intraoperative MAP values in each patient and comparaison between arms.
Time Frame
Maintenance phase
Secondary Outcome Measure Information:
Title
Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)
Description
monitoring device (automatic recorder)
Time Frame
Throughout the maintenance of anesthesia, an expected average of 6 hours
Title
Delay from the surgery to the discharge date
Description
Delay from the date of surgery to the date of hospital discharge (days)
Time Frame
from the surgery to the hospital discharge date
Title
Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
Description
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
Title
Total dose requirement of Vasopressive and hypotensive agents
Time Frame
Throughout the maintenance of anesthesia, an expected average of 6 hours
Title
Volume of each product infused
Time Frame
Throughout the maintenance of anesthesia, an expected average of 6 hours
Title
Total dose of morphine
Description
Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)
Time Frame
Throughout the maintenance of anesthesia, an expected average of 6 hours
Title
Quality of awaking
Description
Modified Aldrete score and Recovery Index
Time Frame
5 minutes after eyes opening
Title
Delay to oral feeding recovery
Description
Time from the date of surgery to the date of first subsequent oral food intake
Time Frame
From surgery to oral feeding reintroduction
Title
Post-operative Adverse Events
Description
Post-operative Adverse Events (according to the NCI-CTC version 4.03)
Time Frame
45 days after surgery
Title
post-operative pain
Description
Score to Visual Analog Scale
Time Frame
At entrance and exit of post operative room and 24 hours after the end of anesthesia
Title
Delay to intestinal transit recovery
Description
Time from the date of surgery to the date of first postoperative stools
Time Frame
Time to postoperative stools

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Léon Bérard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11379681
Citation
Nakata Y, Goto T, Ishiguro Y, Terui K, Kawakami H, Santo M, Niimi Y, Morita S. Minimum alveolar concentration (MAC) of xenon with sevoflurane in humans. Anesthesiology. 2001 Apr;94(4):611-4. doi: 10.1097/00000542-200104000-00014.
Results Reference
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PubMed Identifier
16782975
Citation
Rasmussen LS, Schmehl W, Jakobsson J. Comparison of xenon with propofol for supplementary general anaesthesia for knee replacement: a randomized study. Br J Anaesth. 2006 Aug;97(2):154-9. doi: 10.1093/bja/ael141. Epub 2006 Jun 17.
Results Reference
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PubMed Identifier
18165567
Citation
Salmi E, Laitio RM, Aalto S, Maksimow AT, Langsjo JW, Kaisti KK, Aantaa R, Oikonen V, Metsahonkala L, Nagren K, Korpi ER, Scheinin H. Xenon does not affect gamma-aminobutyric acid type A receptor binding in humans. Anesth Analg. 2008 Jan;106(1):129-34, table of contents. doi: 10.1213/01.ane.0000287658.14763.13.
Results Reference
background
PubMed Identifier
14834873
Citation
CULLEN SC, GROSS EG. The anesthetic properties of xenon in animals and human beings, with additional observations on krypton. Science. 1951 May 18;113(2942):580-2. doi: 10.1126/science.113.2942.580. No abstract available.
Results Reference
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PubMed Identifier
17325504
Citation
Wappler F, Rossaint R, Baumert J, Scholz J, Tonner PH, van Aken H, Berendes E, Klein J, Gommers D, Hammerle A, Franke A, Hofmann T, Schulte Esch J; Xenon Multicenter Study Research Group. Multicenter randomized comparison of xenon and isoflurane on left ventricular function in patients undergoing elective surgery. Anesthesiology. 2007 Mar;106(3):463-71. doi: 10.1097/00000542-200703000-00010.
Results Reference
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PubMed Identifier
17468494
Citation
Baumert JH, Hein M, Hecker KE, Satlow S, Schnoor J, Rossaint R. Autonomic cardiac control with xenon anaesthesia in patients at cardiovascular risk. Br J Anaesth. 2007 Jun;98(6):722-7. doi: 10.1093/bja/aem083. Epub 2007 Apr 27.
Results Reference
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PubMed Identifier
7909641
Citation
Luttropp HH, Thomasson R, Dahm S, Persson J, Werner O. Clinical experience with minimal flow xenon anesthesia. Acta Anaesthesiol Scand. 1994 Feb;38(2):121-5. doi: 10.1111/j.1399-6576.1994.tb03852.x.
Results Reference
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PubMed Identifier
12502972
Citation
Rossaint R, Reyle-Hahn M, Schulte Am Esch J, Scholz J, Scherpereel P, Vallet B, Giunta F, Del Turco M, Erdmann W, Tenbrinck R, Hammerle AF, Nagele P; Xenon Study Group. Multicenter randomized comparison of the efficacy and safety of xenon and isoflurane in patients undergoing elective surgery. Anesthesiology. 2003 Jan;98(1):6-13. doi: 10.1097/00000542-200301000-00005.
Results Reference
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PubMed Identifier
10434815
Citation
Dupont J, Tavernier B, Ghosez Y, Durinck L, Thevenot A, Moktadir-Chalons N, Ruyffelaere-Moises L, Declerck N, Scherpereel P. Recovery after anaesthesia for pulmonary surgery: desflurane, sevoflurane and isoflurane. Br J Anaesth. 1999 Mar;82(3):355-9. doi: 10.1093/bja/82.3.355.
Results Reference
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PubMed Identifier
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Citation
Stuttmann R, Jakubetz J, Schultz K, Schafer C, Langer S, Ullmann U, Hilbert P. Recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia: a randomized controlled trial. BMC Anesthesiol. 2010 May 7;10:5. doi: 10.1186/1471-2253-10-5.
Results Reference
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PubMed Identifier
18952398
Citation
Diemunsch P; Societe francaise d'anesthesie et de reanimation. [Conference of experts--short text. Management of postoperative nausea and vomiting. French Society of Anesthesia and Resuscitation]. Ann Fr Anesth Reanim. 2008 Oct;27(10):866-78. doi: 10.1016/j.annfar.2008.09.004. Epub 2008 Oct 25. No abstract available. French.
Results Reference
background

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Xenon Combined With Intraoperative Thoracic Epidural Analgesia

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