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NCT Number: NCT01696630

Xenon Combined With Intraoperative Thoracic Epidural Analgesia

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Léon Bérard

Lyon, 69373, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

Desflurane

Drug

Primary outcomes

  1. Variation of intraoperative Mean Arterial Pressure (MAP)

    Time frame: 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 outcomes

  1. Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)

    Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours

    monitoring device (automatic recorder)

  2. Delay from the surgery to the discharge date

    Time frame: from the surgery to the hospital discharge date

    Delay from the date of surgery to the date of hospital discharge (days)

  3. Delay between the end of surgery and Post Anesthesia Care Unit's exit (min)

    Time frame: 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)

  4. Total dose requirement of Vasopressive and hypotensive agents

    Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours

  5. Volume of each product infused

    Time frame: Throughout the maintenance of anesthesia, an expected average of 6 hours

  6. Total dose of morphine

    Time frame: 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)

  7. Quality of awaking

    Time frame: 5 minutes after eyes opening

    Modified Aldrete score and Recovery Index

  8. Delay to oral feeding recovery

    Time frame: From surgery to oral feeding reintroduction

    Time from the date of surgery to the date of first subsequent oral food intake

  9. Post-operative Adverse Events

    Time frame: 45 days after surgery

    Post-operative Adverse Events (according to the NCI-CTC version 4.03)

  10. post-operative pain

    Time frame: At entrance and exit of post operative room and 24 hours after the end of anesthesia

    Score to Visual Analog Scale

  11. Delay to intestinal transit recovery

    Time frame: Time to postoperative stools

    Time from the date of surgery to the date of first postoperative stools

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2012
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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