Effects of Remimazolam on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients
Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as airway occlusion pressure (P0.1), airway occlusion pressure (Pocc). However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Remimazolam is a new benzodiazepine sedative developed by adding a methyl propionate side chain to the structure of midazolam. As an organic weak base, remimazolam forms a salt with benzenesulfonic acid, which enhances its solubility and stability. The sedative effect of remimazolam primarily occurs through binding to γ-aminobutyric acid type A (GABAA) receptors, opening chloride channels, promoting chloride ion influx, hyperpolarizing neuronal membranes, and thereby suppressing neuronal excitability. The drug acts rapidly, achieving maximum sedation within three minutes after administration. Research on adverse effects of remimazolam remains limited, particularly regarding its impact on respiratory function. Therefore, this study aims to investigate the effects of remimazolam on breathing patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Beijing、中国
- Beijing Tiantan Hospital
-
-
参加基準
適格基準
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 admitted to the ICU after surgery under general anesthesia;
- Patients with an artificial airway and receiving assisted ventilation in pressure support mode;
- Patients expected to achieve a sedation depth corresponding to a Richmond Agitation and Sedation Scale (RASS) score of -2 to +1;
Exclusion Criteria:
- Patients with brainstem tumors or neuromuscular disorders;
- Patients unable to undergo RASS assessment due to various reasons, such as history of psychiatric disorders (schizophrenia, mania, delirium, cognitive impairment), status epilepticus, or coma;
- Patients with known or suspected allergy or contraindication to any component of the study drug or opioids;
- Severe hepatic dysfunction (Child-Pugh class C);
- Chronic kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m²);
- Mean arterial pressure (MAP) < 65 mmHg, or requiring norepinephrine infusion > 0.5 μg/kg/min to maintain MAP ≥ 65 mmHg;
- Age <18 years old;
- Pregnant or breastfeeding women;
- Body mass index (BMI) <18 kg/m² or >30 kg/m²
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Remimazolam
The investigators conducted a single-arm, prospective physiological trial to assess the respiratory effects of remimazolam. The study enrolled 20 patients receiving invasive mechanical ventilation. Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h. The primary outcomes were changes in breathing pattern (respiratory rate (RR), tidal volume (VT), and minute ventilation (Vmin)), respiratory drive (airway occlusion pressure (P0.1)), and inspiratory effort (pressure muscle index (PMI) and airway occlusion pressure (ΔPocc)) after 0.15 mg/kg/h infusion of remimazolam. |
Remimazolam will be infused at 0.15，0.175，0.20，0.225，0.25，0.275, 0.3 mg/kg/h in sequence for 30 minutes at each dose. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tidal volume
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in tidal volume 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
|
Respiratory rate
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in respiratory rate 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
|
Minute ventilation
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in minute ventilation 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
|
Airway occlusion pressure (P0.1)
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in P0.1 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
|
Pressure muscle index (PMI)
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in PMI 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
|
Airway occlusion pressure (Pocc)
時間枠：At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
The change in Pocc 30 minutes after remimazolam was infused at a rate of 0.15mg/kg/h compared to the baseline level without the use of sedative drugs. |
At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Respiratory rate
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, respiratory rate was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in respiratory rate during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, respiratory rate was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
Tidal volume
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, tidal volume was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in tidal volume during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, tidal volume was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
Minute ventilation
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, minute ventilation was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in minute ventilation during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, minute ventilation was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
P0.1
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, P0.1 was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in P0.1 during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, P0.1 was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
PMI
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, PMI was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in PMI during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, PMI was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
Pocc
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, Pocc was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
Changing trends in Pocc during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, Pocc was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h)
|
|
Richmond Agitation and Sedation Scale (RASS) score
時間枠：Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, RASS score was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h).
|
Changing trends in RASS score during remimazolam infusion from 0.15 mg/kg/h to 0.3 mg/kg/h. The RASS scale ranges from -5 to +4. The lower the score, the deeper the level of sedation. |
Remimazolam was initiated at 0.15 mg/kg/h and increased it by 0.025 mg/kg/h every 30 minutes, up to a maximum of 0.3 mg/kg/h, RASS score was measured after each infusion rate adjustment (0.15，0.175，0.20，0.225，0.25, 0.275, 0.3mg/kg/h).
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Jian-Xin Zhou、Capital Medical University
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- KY2023-182-04
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。