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.
調査の概要
詳細な説明
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
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Quebec
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Montreal、Quebec、カナダ、H1T2M4
- 募集
- Hopital Maisonneuve Rosemont
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コンタクト：
- Philippe Richebe, Md PhD
- 電話番号：+195140743-6558
- メール：philipperichebe@live.com
-
コンタクト：
- Nadia Goding, RN
- 電話番号：3193 514-252-3400
- メール：ngodin.hmr@ssss.gouv.qc.ca
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%.
時間枠：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.
|
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.
|
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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NoL index variation after electrical stimulation in patients under GA atEnd-Tidal N2O 0% and 50%.
時間枠：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.
|
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.
|
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%.
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Philippe Richebe, MD PhD、Maisonneuve-Rosemont Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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