Clinical trial · Interventional
Xenon Combined With Intraoperative Thoracic Epidural Analgesia
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
NCT01696630CI-TRIAL-00023363completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Desflurane | Drug | — | UNRESOLVED |
| Xenon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Desflurane
- description
- Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
- interventionNames
- Drug: Desflurane
- type
- EXPERIMENTAL
- label
- Xenon
- description
- Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
- interventionNames
- Drug: Xenon
Primary outcomes (1)
- measure
- Variation of intraoperative Mean Arterial Pressure (MAP)
- timeFrame
- Maintenance phase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDNakata 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
- BACKGROUNDRasmussen 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
- BACKGROUNDSalmi 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
- BACKGROUNDCULLEN 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
- BACKGROUNDWappler 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
- BACKGROUNDBaumert 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
- BACKGROUNDLuttropp 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.