腹腔鏡下胃切除術を受ける高齢患者における術後せん妄軽減のためのレミマゾラム
高齢者腹腔鏡下胃全摘術患者におけるレミマゾラムの術後せん妄への効果：前向きランダム化比較試験
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.
調査の概要
詳細な説明
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.
Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.
The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiongxiong Pan
- 電話番号：+86 13813801858
- メール：xiongxiong@njmu.edu.cn
研究連絡先のバックアップ
- 名前：Siyang Li
- 電話番号：+86 18745228706
- メール：hilary37727@163.com
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国
- 募集
- The First Affiliated Hospital of Nanjing Medical University
-
コンタクト：
- Xiongxiong Pan
- 電話番号：+86 13813801858
- メール：xiongxiong@njmu.edu.cn
-
コンタクト：
- Siyang Li
- 電話番号：+86 18745228706
- メール：hilary37727@163.com
-
-
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:
- Age ≥ 65 years.
- Body mass index (BMI) between 18 and 28 kg/m².
- ASA physical status I-III.
- Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
- Able and willing to sign informed consent.
Exclusion Criteria:
- Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
- Stroke within the past 6 months or other central nervous system diseases.
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
- History of alcohol abuse or psychoactive substance dependence.
- Severe visual, hearing, or language impairment preventing communication.
- Allergy or contraindication to propofol or benzodiazepines.
- Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).
- Participation in another drug clinical trial within 1 month before 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：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：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：Remimazolam Group
Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. |
|
アクティブコンパレータ：Propofol Group
Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. |
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 |
|---|---|---|
|
incidence of Postoperative Delirium
時間枠：From postoperative Day 1 to Day 3
|
Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm. |
From postoperative Day 1 to Day 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Emergence Agitation
時間枠：Immediately after extubation until PACU discharge
|
Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators. |
Immediately after extubation until PACU discharge
|
|
Time to extubation
時間枠：At the end of surgery
|
Time from discontinuation of anesthetic agents to successful tracheal extubation. |
At the end of surgery
|
|
Postoperative Pain Score
時間枠：At PACU discharge; postoperative day 1,day 2,and day 3.
|
Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10) |
At PACU discharge; postoperative day 1,day 2,and day 3.
|
|
Post-induction Hypotension
時間枠：From completion of anesthetic induction to 10 minutes after induction.
|
Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to <65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction. |
From completion of anesthetic induction to 10 minutes after induction.
|
|
Incidence of Postoperative Nausea and Vomiting
時間枠：From surgery until 48 hours postoperatively
|
Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period. |
From surgery until 48 hours postoperatively
|
|
Length of Hospital Stay(days)
時間枠：From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
|
Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system |
From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
|
協力者と研究者
出版物と役立つリンク
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
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
- 2025-SR-1025
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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