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Phase II Study, Randomized, Monocentric, Single-blind, Comparing the Efficacy of Gases Xenon and Desflurane , in Association With a Thoracic Epidural Analgesia in Maintenance Phase of a Colorectal Oncologic Surgery


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase II Study, Randomized, Monocentric, Single-blind, Comparing the Efficacy of Gases Xenon and Desflurane , in Association With a Thoracic Epidural Analgesia in Maintenance Phase of a Colorectal Oncologic Surgery


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 step 2. 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 step 2. If 1 or more toxicity :
end of the study.

The safety will be assessed after each part by an independent data safety monitoring board.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the fluctuation of peroperative mean Arterial Pressure

Outcome Description:

The initial value (taken just before anesthesia induction) will be compared to the lowest value of mean Arterial Pressure observed during the whole maintenance phase.

Outcome Time Frame:

during the whole maintenance phase, an expected average of 6 hours

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

XENON

NCT ID:

NCT01696630

Start Date:

September 2012

Completion Date:

November 2013

Related Keywords:

  • Colorectal Cancer
  • maintenance of anesthesia
  • Colorectal Neoplasms

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