Thoracic Epidural Versus General Anaesthesia in Cholecystectomy (EVGAC)
Comparison of Bi-spectral Index-Controlled Sedation During a Thoracic Epidural Anesthesia With General Anesthesia in Laparoscopic Cholecystectomy
調査の概要
詳細な説明
This comparative randomized study included 45 patients in this study following receiving institutional ethical committee approval (Clinical Ethical Committee of Abant Izzet Baysal University, Bolu, Turkey. Ethical Committee Number: 2012/234) and collecting informed consent. Pre-anesthetic evaluations were conducted in these patients who were between the ages of 18 and 75 and fell into American Society of Anesthesiologists (ASA) risk categories I-II who were scheduled for elective laparoscopic cholecystectomy. Exclusion criteria; patients with any of the following: allergies against any of the drugs to be used in the study, current pregnancy, severe cardiac, renal, and liver diseases, previous upper abdominal surgery, acute cholangitis, a body mass index >32 kg m2, contraindications for epidural anesthesia and elective surgery.
All the patients received preoperative evaluations, were informed about the study, provided their informed consent, and were informed about the method of anesthesia to be applied In this study, present a comparison of patients and surgical satisfaction and hemodynamic changes of patients for whom an elective laparoscopic cholecystectomy procedure was planned.
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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Bolu、七面鳥、14280
- Abant Izzet Baysal University Medical School,
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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:
- American Society of Anesthesiologists I-II classification ,
- Elective laparoscopic cholecystectomy ,
- Ages of 18 and 75
Exclusion Criteria:
- allergies against any of the drugs to be used in the study,
- current pregnancy,
- severe cardiac, renal, and liver diseases,
- previous upper abdominal surgery,
- acute cholangitis,
- a body mass index >32 kg m2,
- contraindications for epidural anesthesia and elective surgery
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
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アクティブコンパレータ:general anesthesia
In general anesthesia group (Group G), and induction was managed using 1.5 mg/kg fentanyl and 2 mg/kg propofol; 0.5 mg/kg rocuronium and sevoflurane in a 50% oxygen /air mixture was used.
Blood gas analysis monitoring was performed in the 30th minute before and after pneumoperitoneum
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general anesthesia procedure
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実験的:thoracic epidural anesthesia
In epidural anesthesia group(Group E), a catheter was installed and received 20 mg lidocaine hydrochloride, 15 mg bupivacaine, and 25 mg fentanyl citrate adjusted to 10 cc with normal saline to be injected by the epidural catheter.
Bi-spectral index -controlled sedation was provided
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general anesthesia procedure
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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 |
|---|---|---|
|
patient satisfaction
時間枠:after postoperative 24 hour
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four level patient satisfaction scale
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after postoperative 24 hour
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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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mean arterial pressure
時間枠:intaoperative 0, 5, 10, 15, 30, and 45 minutes
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physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
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heart rate
時間枠:intaoperative 0, 5, 10, 15, 30, and 45 minutes
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physiological parameter
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intaoperative 0, 5, 10, 15, 30, and 45 minutes
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Blood gas analysis
時間枠:intaoperative 0 and 35 minutes
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physiological parameter
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intaoperative 0 and 35 minutes
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Hypotension
時間枠:During the operation
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adverse effect, A decrease in the mean arterial pressure under 60 mm Hg was considered to hypotension
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During the operation
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Bradycardia
時間枠:During the operation
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adverse effect,A decrease of the Heart rate under 50 beats per minute was considered bradycardia
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During the operation
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Nausea / vomiting
時間枠:postoperative 24 hour
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adverse effect
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postoperative 24 hour
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Shoulder pain
時間枠:intraoperative and postoperative 24 hour
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adverse effect
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intraoperative and postoperative 24 hour
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Sore throat
時間枠:postoperative 24 hour
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adverse effect
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postoperative 24 hour
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協力者と研究者
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
その他の研究ID番号
- AbantIBU mb2
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
米国で製造され、米国から輸出された製品。
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詳細不明の外科的処置の臨床試験
-
McMaster UniversityIcahn School of Medicine at Mount Sinai; Edward-Elmhurst Health System完了霰粒腫 Unspecified Eye, Unspecified Eyelid | 霰粒腫左目、詳細不明のまぶた | 霰粒腫 右目、詳細不明のまぶた | 霰粒腫両目アメリカ, カナダ