Colorectal Cancer
Conditions
Keywords
anesthesia, epidural anagesia, colorectal surgery, xenon, hemodynamic change
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.
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.
Interventions
DRUGXenon
DRUGDesflurane
Sponsors
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Delay to intestinal transit recovery | Time to postoperative stools | Time from the date of surgery to the date of first postoperative stools |
| 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 | — |
| post-operative pain | At entrance and exit of post operative room and 24 hours after the end of anesthesia | Score to Visual Analog Scale |
| 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) |
| Volume of each product infused | Throughout the maintenance of anesthesia, an expected average of 6 hours | — |
Countries
France
Outcome results
None listed