Xenon Combined With Intraoperative Thoracic Epidural Analgesia

NCT01696630 | Completed Phase 2 DMC

• 3 other identifiers: XENON2012-002155-41ET2012-19
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change

Outcome Measures

Primary Outcomes (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.

  Maintenance phase

Secondary Outcomes (11)

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

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

• Delay from the surgery to the discharge date

  from the surgery to the hospital discharge date

• Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)

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

• Total dose requirement of Vasopressive and hypotensive agents

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

• Volume of each product infused

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

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase

Drug: Desflurane

Xenon

EXPERIMENTAL

Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase

Drug: Xenon

Interventions

Xenon DRUG

Xenon

Desflurane DRUG

Desflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (11)

• 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.

  PMID: 11379681 BACKGROUND

• 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.

  PMID: 16782975 BACKGROUND

• 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.

  PMID: 18165567 BACKGROUND

• 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.

  PMID: 14834873 BACKGROUND

• 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.

  PMID: 17325504 BACKGROUND

• 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.

  PMID: 17468494 BACKGROUND

• 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.

  PMID: 7909641 BACKGROUND

• 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.

  PMID: 12502972 BACKGROUND

• 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.

  PMID: 10434815 BACKGROUND

• 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.

  PMID: 20459661 BACKGROUND

• 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.

  PMID: 18952398 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Xenon; Desflurane

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 1, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

FR (1)