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Colorectal CancerPhase 2NCT01696630

Xenon Combined With Intraoperative Thoracic Epidural Analgesia

A Phase 2 study testing Xenon and Desflurane in people with Colorectal Cancer, run by Centre Leon Berard at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Xenon and Desflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteFrance
Study dates
Oct 2012to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Léon Bérard

    Lyon, 69373

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Xenon, Desflurane
Keywords
anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XenonDrug

  • DesfluraneDrug

Study groups in NCT01696630
Study groupRoleWhat they receive
DesfluraneActive comparatorDesflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
Receives: Drug: Desflurane
XenonExperimentalXenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
Receives: Drug: Xenon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Maintenance phase

Secondary outcomes (11)

  1. Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)

    monitoring device (automatic recorder)

    Measured: Throughout the maintenance of anesthesia, an expected average of 6 hours

  2. Delay from the surgery to the discharge date

    Delay from the date of surgery to the date of hospital discharge (days)

    Measured: from the surgery to the hospital discharge date

  3. 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)

    Measured: from the end of surgery up to Post Anesthesia Care Unit's exit

  4. Total dose requirement of Vasopressive and hypotensive agents

    Measured: Throughout the maintenance of anesthesia, an expected average of 6 hours

  5. Volume of each product infused

    Measured: Throughout the maintenance of anesthesia, an expected average of 6 hours

  6. Total dose of morphine

    Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)

    Measured: Throughout the maintenance of anesthesia, an expected average of 6 hours

  7. Quality of awaking

    Modified Aldrete score and Recovery Index

    Measured: 5 minutes after eyes opening

  8. Delay to oral feeding recovery

    Time from the date of surgery to the date of first subsequent oral food intake

    Measured: From surgery to oral feeding reintroduction

  9. Post-operative Adverse Events

    Post-operative Adverse Events (according to the NCI-CTC version 4.03)

    Measured: 45 days after surgery

  10. post-operative pain

    Score to Visual Analog Scale

    Measured: At entrance and exit of post operative room and 24 hours after the end of anesthesia

  11. Delay to intestinal transit recovery

    Time from the date of surgery to the date of first postoperative stools

    Measured: Time to postoperative stools

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01696630
Sponsor's protocol ID
XENON
Other IDs
2012-002155-41, ET2012-19
Status last verified
Aug 2016
First submitted
21 Sep 2012
Last updated
4 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11379681

  • 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.

    PubMed 16782975

  • 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.

    PubMed 18165567

  • 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.

    PubMed 14834873

  • 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.

    PubMed 17325504

  • 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.

    PubMed 17468494

  • 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.

    PubMed 7909641

  • 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.

    PubMed 12502972

  • 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.

    PubMed 10434815

  • 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.

    PubMed 20459661

  • 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.

    PubMed 18952398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xenon and Desflurane in people with Colorectal Cancer, run by Centre Leon Berard at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of intraoperative Mean Arterial Pressure (MAP) (time frame: Maintenance phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01696630, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.

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