Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery
Comparison of the Effects of Minimal-Flow and High-Flow Sevoflurane on Emergence Agitation in Opioid-Free Pediatric Surgeries During General Anesthesia Maintenance
This study aims to evaluate the effects of minimal-flow sevoflurane compared with high-flow sevoflurane during maintenance of general anesthesia on postoperative emergence agitation in opioid-free pediatric infraumbilical surgeries. Patients will be randomly assigned to receive either opioid-free minimal-flow anesthesia combined with caudal block or opioid-free high-flow anesthesia combined with caudal block.
The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale and the Watcha scale. Secondary outcomes include the incidence of postoperative nausea and vomiting and recovery characteristics. In addition, all patients will be followed up via telephone at 3 months postoperatively to assess the presence of persistent chronic or neuropathic pain at the surgical site.
The findings of this study may contribute to optimizing anesthesia strategies and improving postoperative outcomes in pediatric patients.
調査の概要
詳細な説明
Emergence agitation (EA) is a common and clinically significant complication in pediatric patients following general anesthesia, particularly after the use of volatile anesthetic agents such as sevoflurane. The etiology of EA is multifactorial and may be associated with rapid emergence, postoperative pain, preoperative anxiety, and the use of opioids. Strategies aimed at reducing opioid consumption and optimizing anesthetic techniques may help improve postoperative recovery profiles in children.
Opioid-free anesthesia (OFA) has gained increasing attention as a multimodal approach that minimizes or eliminates intraoperative opioid use while maintaining adequate analgesia and hemodynamic stability. In addition, low-flow anesthesia techniques may contribute to improved respiratory conditions, better humidification, and more stable anesthetic depth, which could potentially influence emergence characteristics. However, the combined effect of opioid-free and low-flow anesthesia on emergence agitation in pediatric populations has not been sufficiently investigated.
In this prospective, randomized, single-blind study, pediatric patients undergoing infraumbilical surgery will be allocated to receive either opioid-free minimal-flow anesthesia combined with caudal epidural block or conventional anesthesia management. Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale as the primary outcome, and the Watcha scale as a secondary assessment tool. Additional outcomes include postoperative pain scores, incidence of postoperative nausea and vomiting (PONV), and recovery parameters. This study aims to provide evidence on whether opioid-free minimal-flow anesthesia can improve postoperative behavioral outcomes and enhance recovery quality in pediatric patients.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Ankara、トルコ（Türkiye）
- Ankara Bilkent City Hospital
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Pediatric patients aged 2-10 years
- ASA physical status I-II
- Scheduled for elective infraumbilical surgery
- Planned to receive general anesthesia with caudal block
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- - Refusal of parental consent
- Known allergy to study drugs
- Neurological or developmental disorders
- Psychiatric disorders or use of psychoactive medications
- Chronic pain or regular analgesic use
- Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
- Significant cardiovascular, respiratory, hepatic, or renal disease
- Emergency surgery
- Signs of failed caudal epidural block, defined as a greater than 20% increase in heart rate or blood pressure in response to surgical stimulation, an increase in bispectral index (BIS) values, or the requirement for additional intravenous anesthetic agents.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：opioid-free minimal-flow anesthesia
In this arm, pediatric patients undergoing infraumbilical surgery under opioid-free general anesthesia receive a caudal epidural block after tracheal intubation.
Anesthesia is then maintained with minimal-flow sevoflurane.
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In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
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実験的：Opioid-Free High-Flow anesthesia
Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.
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In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
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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 |
|---|---|---|
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Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale
時間枠：First 30 minutes in PACU
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Pediatric Anesthesia Emergence Delirium (PAED) Scale score ranging from 0 to 20 points.
Higher scores indicate more severe emergence delirium.
Emergence delirium will be defined as a PAED score ≥10.
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First 30 minutes in PACU
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Emergence agitation assessed by Watcha scale
時間枠：First 30 minutes in the post-anesthesia care unit (PACU)
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Emergence agitation will be assessed using the Watcha scale (1-4 points), with higher scores indicating more severe agitation.
Patients with a Watcha score ≥3 will be classified as having emergence agitation.
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First 30 minutes in the post-anesthesia care unit (PACU)
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Hendren WH. From an acorn to an oak. J Pediatr Surg. 1999 May;34(5 Suppl 1):46-58. doi: 10.1016/s0022-3468(99)90830-8. No abstract available.
- Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH; Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010 Feb 1;110(2):354-64. doi: 10.1213/ANE.0b013e3181c84ba5. Epub 2009 Dec 10.
- Enooku K, Kato R, Ikeda H, Kurano M, Kume Y, Yoshida H, Ono T, Aizawa K, Suzuki T, Yamazaki T, Yatomi Y. Inverse correlations between serum ADAMTS13 levels and systolic blood pressure, pulse pressure, and serum C-reactive protein levels observed at a general health examination in a Japanese population: a cross-sectional study. Clin Chim Acta. 2013 Jun 5;421:147-51. doi: 10.1016/j.cca.2013.03.012. Epub 2013 Mar 21.
- Kopterides P, Kapetanakis T, Siempos II, Magkou C, Pelekanou A, Tsaganos T, Giamarellos-Bourboulis E, Roussos C, Armaganidis A. Short-term administration of a high oxygen concentration is not injurious in an ex-vivo rabbit model of ventilator-induced lung injury. Anesth Analg. 2009 Feb;108(2):556-64. doi: 10.1213/ane.0b013e31818f10f7.
- Ryalino C, Senapathi TGD, Pradhana AP, Yudikusumo A. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian J Pharm Clin Res. 2019;12(5):139-141. doi:10.22159/ajpcr.2019.v12i5.32508
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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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