A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
調査の概要
詳細な説明
After approval Institutional Review Board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. By a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (Group LS) or the high dose (2.5%) end tidal concentration of sevoflurane group (Group HS). The patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. Then the patients were into the operating room, applied electrocardiography (ECG), pulse oximetry, and noninvasive blood pressure. Respiratory rate and end tidal carbon dioxide (CO2) were monitored via face mask. After baseline vital signs were monitored, the patient was posed in lateral Sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 G needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. All of these procedures were performed by one skilled anesthesiologist who blinded about the study group. After caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. If oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. If analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly.
In the postanesthetic care unit (PACU), the investigators observed EA episodes at 5 and 30 min after PACU arrival using Four-point agitation scale and Pediatric Anesthesia Emergence Delirium (PAED) scale, and if a total score of PAED scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. EA was considered as an Four-point agitation scale > 3 or PAED scale > 10.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1
Exclusion Criteria:
- Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.
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:トリプル
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:low volume volatile anesthetics
1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
|
low volume volatile anesthetics (1.0%)
他の名前:
|
|
アクティブコンパレータ:high volume volatile anesthetics
2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
|
high volume volatile anesthetics (2.5%)
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 |
|---|---|---|
|
postoperative agitation score
時間枠:5 minutes in the recovery room
|
Four-point agitation scale
|
5 minutes in the recovery room
|
|
postoperative agitation score
時間枠:30 minutes in the recovery room
|
Four-point agitation scale
|
30 minutes in the recovery room
|
|
postoperative agitation score
時間枠:5 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
5 minutes in the recovery room
|
|
postoperative agitation score
時間枠:30 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
30 minutes in the recovery room
|
協力者と研究者
捜査官
- 主任研究者:Eun kyung Choi, MD,PhD、Yeungnam University Hospital
出版物と役立つリンク
一般刊行物
- Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- YUMC 2017-04-12
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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出現アジテーションの臨床試験
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Bozok University募集術後合併症 | 小児患者 | 術前不安(Ameliyat Öncesi Anksiyete) | Emergence Delirium (覚醒時せん妄)トルコ(Türkiye)