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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Variation of intraoperative Mean Arterial Pressure (MAP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Desflurane
Desflurane 6.5% (+/-0.5%) in association with a thoracic epidural analgesia in maintenance phase
干预措施: Desflurane (Drug)
Xenon
Xenon 60% (+/-5%) in association with a thoracic epidural analgesia in maintenance phase
干预措施: Xenon (Drug)
结局指标
主要结局
Variation of intraoperative Mean Arterial Pressure (MAP)
时间窗: 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.
次要结局
- Measure of hemodynamic parameters (Systolic Ejection Volume, Heart rate, DeltaPP)(Throughout the maintenance of anesthesia, an expected average of 6 hours)
- Delay from the surgery to the discharge date(from the surgery to the hospital discharge date)
- 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)
- 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)
- Quality of awaking(5 minutes after eyes opening)
- Delay to oral feeding recovery(From surgery to oral feeding reintroduction)
- Post-operative Adverse Events(45 days after surgery)
- post-operative pain(At entrance and exit of post operative room and 24 hours after the end of anesthesia)
- Delay to intestinal transit recovery(Time to postoperative stools)