Lidocaine on Early Cognitive Dysfunction in Shoulder Arthroscopy
Neuroprotective Effects of Lidocaine on Early Postoperative Cognitive Dysfunction in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position: a Randomized Trial
調査の概要
詳細な説明
Arthroscopic diagnosis and treatment of shoulder disorders have replaced open procedure as the primary treatment method. The beach chair (BCP) and lateral decubitus (LDP) positions are both considered as reliable techniques for performing effective arthroscopic shoulder surgeries. The usage of BCP for shoulder arthroscopic operations started from early 1980s.
The advantages of BCP include lack of brachial plexus strain, good intra-articular visualization, with the ease of conversion to an open approach if required.
The BCP combined with deliberate hypotension has been used to decrease intraoperative blood loss and allow a relatively blood-free surgical field. However, this combination has the risk to impair cerebral perfusion pressure and oxygenation during surgery and produce cerebral ischemia.
Lidocaine, a commonly used local anesthetic and class IB antiarrhythmic drug, that readily crosses the blood - brain barrier. Evans et al. initially reported cerebral protection of lidocaine in a feline model of cerebral arterial gas embolism. Later on, the effects of lidocaine on perioperative neuroprotection were detected. However, the mechanisms underlying lidocaine treatment-induced neuroprotection remain incompletely understood.
Lidocaine may provide cerebral protection through many mechanisms, including decreasing the cerebral metabolic rate, decelerating the ischemic transmembrane ion shift, and reducing the ischemic excitotoxin release.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Asyut
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Assiut、Asyut、エジプト、71515
- 募集
- Seham Mohamed Moeen
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コンタクト：
- Seham M Moeen, MD
- 電話番号：02 01006386324
- メール：seham.moeen@yahoo.com
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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:
- Patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (BCP),
- Age 20 to 65 years old.
Exclusion Criteria:
- Mini-Mental State Examination (MMSE) score < 23 before surgery
- History of neurological disease (such as previous episodes of cerebral ischemia or stroke).
- History of psychological disorder
- Suspected history of adverse reactions to lidocaine
- Drug or alcohol abuse
- History of diabetes mellitus, sever hypertension, severe anemia, hepatic or renal dysfunction
- Unwillingness to comply with protocol.
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：4倍
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：Group L
Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery.
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Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery
他の名前：
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プラセボコンパレーター：Group C
Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery.
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Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery
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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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Postoperative cognitive function
時間枠：3 days after surgery
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Assessed using Mini-Mental State Examination (MMSE) test
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3 days after surgery
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
- SM 2020
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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