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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Beijing, Kína
- Beijing Tiantan Hospital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Tidal volume
Időkeret: At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
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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
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Respiratory rate
Időkeret: At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
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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
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Minute ventilation
Időkeret: At baseline (before sedation with remimazolam) and 0.15 mg/kg/h remimazolam continuous infusion for 30 minutes
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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
|
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Airway occlusion pressure (P0.1)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Respiratory rate
Időkeret: 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)
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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)
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Tidal volume
Időkeret: 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)
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Minute ventilation
Időkeret: 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)
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P0.1
Időkeret: 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)
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PMI
Időkeret: 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)
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Pocc
Időkeret: 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)
|
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Richmond Agitation and Sedation Scale (RASS) score
Időkeret: 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).
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Jian-Xin Zhou, Capital Medical University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- KY2023-182-04
Terv az egyéni résztvevői adatokhoz (IPD)
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