ANI and NoL Index Variations After Standard Nociceptive Stimulus at 0, 50, 25 % of Inhaled N2O in the Anesthetic Mixture
Assessment of the Intraoperative Analgesic Effect of 50%/50% N2O/O2 Inhalation by the Pain Index ANI Following a Standardized Electrical Stimulus in Patients Under Anesthesia. Comparison to the New NoL Analgesic Index.
研究概览
详细说明
Title: Assessment of the intraoperative analgesic effect of 50%/50% Nitrous Oxide / Oxygen inhalation by the pain index ANI following a standardized electrical forearm stimulus in patients undergoing laparotomies under general anesthesia and with an intraoperative active epidural analgesia. Comparison to the new NoL analgesic index.
Objectives: To observe the variations of the intraoperative pain indexes ANI and NoL after a classical and standardized electrical stimulation of the forearm (applied with the commonly used nerve stimulator we use for muscle relaxation monitoring) at different concentrations of inhaled Nitrous Oxide (N2O) (from 0% to 50%, concentrations that are commonly used in daily anesthesia). This will allow a quantification of the analgesic effect of N2O.
Study Design: Prospective, open label, observational and descriptive study Subject Population: Adult patients scheduled to undergo abdominal surgery by laparotomy under general anesthesia with an active intraoperative epidural analgesia Sample Size: 40 patients will be evaluated in this study Study Duration: 1 year Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Nadia Godin, RN
- 电话号码：3193 514-252-3400
- 邮箱：ngodin.hmr@ssss.gouv.qc.ca
研究联系人备份
- 姓名：Philippe Richebe, MD PhD
- 电话号码：+1-514-743-6558
- 邮箱：philipperichebe@live.com
学习地点
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Quebec
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Montreal、Quebec、加拿大、H1T2M4
- 招聘中
- Hôpital Maisonneuve Rosemont
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接触：
- Philippe Richebe, Md PhD
- 电话号码：+195140743-6558
- 邮箱：philipperichebe@live.com
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接触：
- Nadia Goding, RN
- 电话号码：3193 514-252-3400
- 邮箱：ngodin.hmr@ssss.gouv.qc.ca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA status I, II or III
- Patients aged 18 to 70 years
- Laparotomy for gynecological or bowel surgery
- Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed prior the general anesthesia induction and an arterial line placed after induction of general anesthesia
Exclusion Criteria:
- When 100% O2 ventilation is required during anesthesia (except for the induction phase during which all the patients receive O2 100%).
- Patients having received intraocular injection of gas (such as SF6, C3F8, C2F6) within 3 months prior to the present surgery.
Any condition where internal entrapped air could expand and become dangerous, such as:
- head injury within 6 months prior to surgery
- maxillofacial injuries within 6 months prior to surgery
- pneumothorax within 6 months prior to surgery
- gas embolism within 6 months prior to surgery
- decompression sickness within 6 months prior to surgery
- bubbles of emphysema known for this patient
- middle ear, inner ear and sinus surgery
- major abdominal distension/occlusion and emergent surgery for intestinal obstruction
- if air has been injected into the epidural space to determine the placement of the needle for epidural anesthesia (only saline is used in our center for the loss of resistance technique to place the catheter into the epidural space)
Any contra-indication or patient's refusal for epidural placement
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- Unexpected surgical complications requiring strong haemodynamic support (transfusions, volume challenges, vasopressors, inotropic drugs).
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：N2O exposure
There is only one arm in this study.
All patients under General Anesthesia are exposed to 4 different doses or concentrations of inhaled N2O that is combined with the anesthetic desflurane.
Each patient will be submitted to the standard nociceptive stimulus when inhaled N2O is at 0, 50, 25, and finally back to 0%.
ANI and NoL Indices variations between "before stimulus" and "after stimulus" at each N2O concentration will be assessed and compared.
This will allow to demonstrate an analgesic effect (less variations of ANI and NoL) when inhaled N2O is high (50%) testifying for the analgesic effect of this gas N2O.
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The aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%.
大体时间：First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
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The same patient is anesthetized without N2O in the gas mixture first.
The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. ANI response to the stimulus is recorded.
Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture.
Then, at ET-N2O 50%, the same standard stimulus is applied and ANI variations registered.
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First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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NoL index variation after electrical stimulation in patients under GA atEnd-Tidal N2O 0% and 50%.
大体时间：First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
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The same patient is anesthetized without N2O in the gas mixture first.
The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. NoL response to the stimulus is recorded.
Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture.
Then, at ET-N2O 50%, the same standard stimulus is applied and NoL variations registered.
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First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.
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ANI and NoL indices variations after the same standard stimulus when ET-N2O is slowly decreased from 50% to 25%, , then to 0%.
大体时间：Within the same anesthesia and surgery
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During the surgery, for primary and secondary objectives, N2O will be at 0, then 50%. For these secondary objectives, N2O inhaled concentration in teh anesthetic mixture will be set at 25% and then again at 0% and the same standard stimulus will be applied and ANI and NoL responses recorded and compared to the ones gotten at 50% . |
Within the same anesthesia and surgery
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合作者和调查者
调查人员
- 首席研究员：Philippe Richebe, MD PhD、Maisonneuve-Rosemont Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
N2O exposure的临床试验
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University of ChicagoNational Institute on Drug Abuse (NIDA)完全的
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University of Georgia招聘中消息曝光（顺序：Regular Then Flavor） | 消息曝光（顺序：Flavor Then Regular） | 无消息暴露（控制条件）美国