Xenon Combined With Intraoperative Thoracic Epidural Analgesia

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696630
• Other study ID #: XENON
• Secondary ID: 2012-002155-41ET
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2012
• Last updated: August 3, 2016
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2016
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Xenon

• Desflurane

Locations

Country	Name	City	State
France	Centre Léon Bérard	LYON Cedex 08

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Delay from the surgery to the discharge date	Delay from the date of surgery to the date of hospital discharge (days)	from the surgery to the hospital discharge date	No
Secondary	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	No
Secondary	Total dose requirement of Vasopressive and hypotensive agents		Throughout the maintenance of anesthesia, an expected average of 6 hours	No
Secondary	Volume of each product infused		Throughout the maintenance of anesthesia, an expected average of 6 hours	No
Secondary	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	No
Secondary	Quality of awaking	Modified Aldrete score and Recovery Index	5 minutes after eyes opening	No
Secondary	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	No
Secondary	Post-operative Adverse Events	Post-operative Adverse Events (according to the NCI-CTC version 4.03)	45 days after surgery	Yes
Secondary	post-operative pain	Score to Visual Analog Scale	At entrance and exit of post operative room and 24 hours after the end of anesthesia	No
Secondary	Delay to intestinal transit recovery	Time from the date of surgery to the date of first postoperative stools	Time to postoperative stools	No