Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients
Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
調査の概要
状態
詳細な説明
Obesity is associated with physiological alterations that may increase the risk of postoperative cognitive dysfunction (POCD). The influence of anesthetic techniques on postoperative cognitive outcomes in obese patients remains uncertain.
This prospective randomized study was conducted in obese patients (BMI ≥30 kg/m²) aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients were randomly assigned to one of three groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Anesthetic depth was monitored using bispectral index (BIS) monitoring and maintained between 40 and 60 in all groups.
The primary objective was to compare postoperative cognitive function among the three anesthetic techniques using the Mini-Mental State Examination (MMSE). MMSE scores were evaluated preoperatively, at postoperative 30 minutes, and on postoperative day 3.
Secondary objectives included comparison of recovery characteristics, including eye-opening time, extubation time, Modified Aldrete Recovery Scores, and perioperative hemodynamic parameters.
The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2022.744) and written informed consent was obtained from all participants before enrollment.
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
-
-
Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34899
- Marmara University Faculty of Medicine Pendik Training and Research Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age between 18 and 65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective laparoscopic abdominal surgery
- Provision of written informed consent
Exclusion Criteria:
- History of psychiatric disease
- Dementia or known cognitive impairment
- Hearing or language disorders preventing MMSE assessment
- Refusal to participate
- Conversion from laparoscopic to open 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Low-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 1 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
|
|
実験的：Normal-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 3 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
|
|
実験的：Total Intravenous Anesthesia (TIVA)
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.
|
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 |
|---|---|---|
|
Mini-Mental State Examination (MMSE) Score
時間枠：Preoperative, postoperative 30 minutes, and postoperative day 3
|
Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
|
Preoperative, postoperative 30 minutes, and postoperative day 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Eye Opening Time
時間枠：End of surgery
|
Time from discontinuation of anesthetic administration to spontaneous eye opening
|
End of surgery
|
|
Extubation Time
時間枠：End of surgery
|
Time from discontinuation of anesthetic administration to tracheal extubation.
|
End of surgery
|
|
Modified Aldrete Recovery Score
時間枠：Postoperative recovery period
|
Recovery status assessed using the Modified Aldrete Score.
|
Postoperative recovery period
|
|
heart rate
時間枠：During surgery
|
patient's intraoperative measured heart rate
|
During surgery
|
|
mean arterial pressure
時間枠：during surgery
|
patient's intraoperative measured mean arterial pressure
|
during surgery
|
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oxygen saturation
時間枠：During surgery
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oxygen saturation of the patient will be recorded
|
During surgery
|
|
end-tidal carbon dioxide
時間枠：During surgery
|
end-tidal carbon dioxide of the patient will be recorded
|
During surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ahmet Tunca, MD、Department of Anesthesiology and Reanimation, Gaziantep City Hospital
- スタディチェア：Seniyye Ü Zengin, MD、Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
- スタディディレクター：Meliha O Ergün, MD、Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
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
- MU-09.2022.744
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?
IPD プランの説明
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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