Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence
キーワード
概要
説明
This prospective randomized interventional single-blind study aims to compare the influence of the anaesthesiology management no the incidence of ED in the postoperative period in paediatric patients. Elective paediatric patients (2-10 years) scheduled for the planned adenoidectomy or adenoidectomy + micro-otoscopy/adenoidectomy + frenulum linguae discission will be included in the trial after signed informed consent form the legal guardian. In all patients, the 2 Eutectic Mixture of Local Anesthetics (EMLA) patch will be applied on the predefined skin area ( visible vein for venepuncture) between 45 minutes to 60 minutes before anaesthesia. The patients will be randomized at the operating theatre (allocation 1:1) into the experimental group (intravenous induction with propofol + opioid and anaesthesia maintenance according to this set bispectral index value with desflurane) and the control group (inhalation induction with sevoflurane mixed with air and oxygen and anaesthesia maintenance with sevoflurane). The primary aim of the study will be the incidence of ED defined by The Pediatric Anesthesia Emergence Delirium (PAED) scale, which will be measured at the , at the admission to PACU and in the 5th, 10th, 15th, 30th minute and at the moment of dismission from PACU. The secondary aim will be the time to oral intake (from the end of the surgery), the incidence of adverse events (PONV, bradycardia, hypotension), the need for concomitant medication (analgesic medication, sedative medication, antiemetic medication).
日付
| 最終確認済み: | 05/31/2020 |
| 最初に提出された: | 02/25/2020 |
| 提出された推定登録数: | 02/27/2020 |
| 最初の投稿: | 03/01/2020 |
| 最終更新が送信されました: | 06/02/2020 |
| 最終更新日: | 06/04/2020 |
| 実際の研究開始日: | 12/31/2020 |
| 一次完了予定日: | 12/30/2023 |
| 研究完了予定日: | 12/30/2023 |
状態または病気
介入/治療
Procedure: Intravenous induction with desflurane maintenance
Procedure: Inhalation induction with sevoflurane,sevoflurane maintenance
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Intravenous induction with desflurane maintenance The EMLA patch will be removed, and intravenous induction with propofol + opioid will be performed. The anaesthesia will be maintained with desflurane according to the levels of Bispectral index (BIS). Neuromuscular blockade is optional based on operator decision. | Procedure: Intravenous induction with desflurane maintenance Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels |
| Active Comparator: Inhalation induction with sevoflurane,sevoflurane maintenance The EMLA patch will be removed, and inhalation induction with the sevoflurane will be performed. After peripheral vein cannulation, the opioid will be administered. The neuromuscular blockade is optional based on operator decision. Anaesthesia will be maintained with sevoflurane according to the set BIS levels. | Procedure: Inhalation induction with sevoflurane,sevoflurane maintenance Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels |
適格基準
| 研究の対象となる年齢 | 2 Years に 2 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - age between 2-10 years - signed informed consent - paediatric patient for elective adenoidectomy, or adenoidectomy with micro-otoscopy and/or frenulum discission Exclusion Criteria: - allergy and hypersensitivity on local anaesthetics in EMLA patch, general anaesthetics, or soya beans or peanuts - venepuncture refusal · neuromuscular disorder with the contraindication of inhalation anaesthetics |
結果
主な結果の測定
1. Emergence delirium incidence [postoperative period, up to 1 hour postoperatively]
二次的な結果の測定
1. Time to first oral intake [postoperative period, up to 1 hour postoperatively]
2. Adverse events incidence [postoperative period, up to 1 hour postoperatively]
3. The need for concomitant medication in PACU [postoperative period, up to 1 hour postoperatively]
