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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002155-41 | EudraCT Number | ||
| ET2012-19 | Other Identifier | Sponsor's number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Active Comparator | Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase |
|
| Xenon | Experimental | Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug |
| ||
| Desflurane |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP) | monitoring device (automatic recorder) | Throughout the maintenance of anesthesia, an expected average of 6 hours |
| Delay from the surgery to the discharge date |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69373 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11379681 | Background | 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. | |
| 16782975 | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D005019 |
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|
Delay from the date of surgery to the date of hospital discharge (days)
| from the surgery to the hospital discharge date |
| 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) | 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 |
| Total dose of morphine | Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg) | Throughout the maintenance of anesthesia, an expected average of 6 hours |
| Quality of awaking | Modified Aldrete score and Recovery Index | 5 minutes after eyes opening |
| Delay to oral feeding recovery | Time from the date of surgery to the date of first subsequent oral food intake | From surgery to oral feeding reintroduction |
| Post-operative Adverse Events | Post-operative Adverse Events (according to the NCI-CTC version 4.03) | 45 days after surgery |
| post-operative pain | Score to Visual Analog Scale | At entrance and exit of post operative room and 24 hours after the end of anesthesia |
| Delay to intestinal transit recovery | Time from the date of surgery to the date of first postoperative stools | Time to postoperative stools |
| 18165567 | 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. |
| 14834873 | 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. |
| 17325504 | 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. |
| 17468494 | 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. |
| 7909641 | 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. |
| 12502972 | 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. |
| 10434815 | 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. |
| 20459661 | 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. |
| 18952398 | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |