Xenon Combined With Intraoperative Thoracic Epidural Analgesia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Desflurane Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase |
Drug: Desflurane
|
| Experimental: Xenon Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase |
Drug: Xenon
|
Outcome Measures
Primary Outcome Measures
- Variation of intraoperative Mean Arterial Pressure (MAP) [Maintenance phase]
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) [Throughout the maintenance of anesthesia, an expected average of 6 hours]
monitoring device (automatic recorder)
- Delay from the surgery to the discharge date [from the surgery to the hospital 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) [from the end of surgery up to Post Anesthesia Care Unit's exit]
Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)
- 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 [Throughout the maintenance of anesthesia, an expected average of 6 hours]
Total dose of morphine required to maintain BIS between 40 and 60 (in mg/kg)
- Quality of awaking [5 minutes after eyes opening]
Modified Aldrete score and Recovery Index
- Delay to oral feeding recovery [From surgery to oral feeding reintroduction]
Time from the date of surgery to the date of first subsequent oral food intake
- Post-operative Adverse Events [45 days after surgery]
Post-operative Adverse Events (according to the NCI-CTC version 4.03)
- post-operative pain [At entrance and exit of post operative room and 24 hours after the end of anesthesia]
Score to Visual Analog Scale
- Delay to intestinal transit recovery [Time to postoperative stools]
Time from the date of surgery to the date of first postoperative stools
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Bérard | LYON Cedex 08 | France | 69373 |
Sponsors and Collaborators
- Centre Leon Berard
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2007 Apr 27.
- 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.
- Diemunsch P; Société française d'anesthésie et de réanimation. [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. French.
- 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.
- 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.
- 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.
- 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. Epub 2006 Jun 17.
- 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.
- Salmi E, Laitio RM, Aalto S, Maksimow AT, Långsjö JW, Kaisti KK, Aantaa R, Oikonen V, Metsähonkala L, Någren 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.
- Stuttmann R, Jakubetz J, Schultz K, Schäfer 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.
- 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.
- XENON
- 2012-002155-41
- ET2012-19