気管内チューブとプロシール ラリンジアル マスク エアウェイによる換気のための麻酔要件の比較
腹腔鏡下胆嚢摘出術を受ける患者における自動フィードバックループ制御全静脈麻酔中の気管内チューブ対 ProSeal ラリンジアルマスク気道による換気の麻酔要件：無作為化対照研究
Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in particular the laryngeal mask airway (LMA) and its variants have become a reliable alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various advantages of LMA includes, a lower incidence of postoperative sore throat and superior haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited.
By measuring the anaesthesia requirement using a robust computerised delivery system such as the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia required for maintaining intraoperative mechanical ventilation with the use of these two (ETT and PLMA) airway management devices.
This randomised controlled study aims to calculate the anaesthesia requirement as determined by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA
調査の概要
詳細な説明
Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anesthesia (GA). However, since the introduction of classic laryngeal mask airway (LMA) in the 1980's and serial evolution of supra-glottic airway devices (SGA) thereafter, LMAs have become a reliable alternative to ETT for carrying out controlled ventilation. Interestingly, of the additional advantages that the LMA proffers, including, a lower incidence of postoperative sore throat (POST) and superior hemodyamic profile during surgery; its ability to maintain equivalent depth of anesthesia (in comparison to when ETT-GA) with lower anesthetic requirement, is intriguing.
A handful of studies have demonstrated that the end-tidal isoflurane concentration required for maintenance of GA is 0.2 -0.53% greater with use of ETT as compared to LMA. However, the evidence generated by these studies remains unsubstantiated because in them, anaesthetic gas concentration was titrated to patient's clinical profile like heart rate and blood pressure without the backing of specific protocol for maintaining depth-of-anaesthesia. Therefore, for credible evidence, assessment of quantitative anesthetic requirement for achieving and sustaining a steady anesthesia depth with either LMA or ETT warrants confirmation with the use of an objective depth-of-anesthesia monitor, such as, bispectral index (BIS).
Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (502/DEL/2003) computer-controlled and BIS-guided automated anesthesia delivery system. CLADS, which runs on a control algorithm based on the relationship between diverse rates of propofol infusion and the processed EEG variable; delivers propofol infusion at a rate which is continuously adjusted by patient's state of depth of anesthesia as per BIS monitoring input. This automated system maintains anaesthesia depth with high accuracy and objectively determines propofol delivery quantitatively.
Of the several variants of SGA available today, the ProSeal laryngeal mask airway (PLMA) 9 is preferred for controlled ventilation for its unique design that serves dual function of a ventilation tube and an oropharyngeal drainage tube for excluding gastric contents from getting aspirated through the peri-laryngeal cuff seal.
Given that CLADS can help us to accurately quantify anaesthesia, we hypothesize that there is no difference in anesthesia requirement for GA maintained through an ETT or a PLMA. This randomized controlled study aims to compare: anaesthesia requirement as determined by total propofol consumption (primary objective); intraoperative hemodynamic profile and incidence of POST (secondary objectives) in patients undergoing laparoscopic surgery with controlled ventilation via ETT or PLMA.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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National Capital Territory of Delhi
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New Delhi、National Capital Territory of Delhi、インド、110060
- Sir Ganga Ram Hospital
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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 physical status I/II
- Undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
- Anticipated difficult airway
- Body mass index > 30-kg/m2
- Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)
- Hepato-renal insufficiency
- Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
- Known allergy/hypersensitivity to the study drug (propofol)
- Drug dependence/substance abuse/psychiatric illness
- Requirement of postoperative ventilation
- Refusal to informed consent
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：ETT Group
Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. Intraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID). |
After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. |
|
アクティブコンパレータ：PLMA Group
Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted. |
After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. |
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 |
|---|---|---|
|
Change in Propofol usage in milligrams
時間枠：From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
|
Comparison of quantitative difference in propofol requirement between the two groups |
From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anaesthesia depth consistency using BIS scores
時間枠：From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms. |
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
|
Evaluation of propofol anaesthesia delivery system
時間枠：From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms |
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
|
Change in Intra-operative heart Rate (beats per minute)
時間枠：From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
Comparison of intra-operative heart rate between both the arms will be done |
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
|
|
Change in Intra-operative systolic , diastolic, and mean (mmHg)
時間枠：From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
|
Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done |
From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
|
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Early Recovery from anesthesia
時間枠：From end of anaesthesia till 20-minutes postoperatively
|
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted |
From end of anaesthesia till 20-minutes postoperatively
|
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Post operative sedation
時間枠：From the end of anaesthesia till 24-hours, postoperatively
|
Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S) |
From the end of anaesthesia till 24-hours, postoperatively
|
|
Incidence of postoperative sore throat
時間枠：From the end of anaesthesia till 24-hours, postoperatively
|
Comparison of post operative sore throat occurrence between the two groups |
From the end of anaesthesia till 24-hours, postoperatively
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nitin Sethi, DNB、Sir Ganga Ram Hospital
- スタディディレクター：Amitabh Dutta, MD、Sir Ganga Ram Hospital
- スタディチェア：Jayashree Sood, MD, FFRCA、Sir Ganga Ram Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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