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Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU

18 maggio 2026 aggiornato da: Jingyuan,Xu, Southeast University, China
The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.

Panoramica dello studio

Descrizione dettagliata

Worldwide, approximately 13-20 million patients receive mechanical ventilation in intensive care units (ICUs) each year. As a crucial life-support modality, mechanical ventilation is widely used for the management of respiratory failure due to various causes, as well as for respiratory support during anesthesia and after surgery. However, mechanical ventilation may also induce anxiety, pain, and patient-ventilator asynchrony, leading to increased oxygen consumption, a higher risk of barotrauma, and potentially worse patient outcomes. Therefore, patients undergoing mechanical ventilation usually require sedatives to improve comfort and safety, reduce anxiety, optimize ventilation efficacy, and decrease the incidence of complications.

In current clinical practice, various sedatives such as midazolam, propofol, and dexmedetomidine are widely used, all of which can effectively achieve sedation. Midazolam is a classic benzodiazepine sedative widely used in the ICU. It exerts central inhibitory effects by enhancing γ-GABA-mediated neurotransmission, thereby producing sedation, anxiolysis, and anterograde amnesia. However, it has a relatively slow onset and tends to accumulate in the body, leading to prolonged recovery time. Propofol is known for its rapid onset, short duration of action, and quick recovery after discontinuation. Its depth of sedation is positively correlated with the administered dose. Nevertheless, propofol may increase hemodynamic instability by reducing vascular tone and decreasing venous return, and it also exerts respiratory depression. Moreover, high-dose or long-term use of propofol can potentially cause fatal propofol infusion syndrome. Dexmedetomidine, a selective α2-adrenergic receptor agonist, reduces sympathetic overactivity by inhibiting norepinephrine release from the locus coeruleus and competitively binding to α2 receptors, thereby producing sedation, anxiolysis, and mild analgesia. Patients sedated with dexmedetomidine are relatively easy to arouse and have a lower incidence of respiratory depression, but this drug tends to cause hypotension and bradycardia.

Remimazolam, a novel ultra-short-acting benzodiazepine sedative, exerts its sedative effects by binding to and enhancing the activity of GABAA receptors, thereby reducing neuronal excitability. It features rapid onset, predictable sedative effect, lack of accumulation in the body, quick metabolism, mild cardiorespiratory depression, and low dependence on hepatic and renal function. The sedative effect of remimazolam can be reversed by the specific benzodiazepine antagonist flumazenil. Given these properties, remimazolam is considered an ideal sedative in the ICU and an excellent choice for sedation in critically ill patients. In recent years, it has been gradually applied in procedural sedation and general anesthesia. In a multicenter, randomized, single-blind, non-inferiority trial of mechanically ventilated ICU patients, remimazolam was found to be non-inferior to propofol in achieving short-term light sedation. In addition, a preliminary study by Tang Y and colleagues showed that remimazolam was similarly effective and safe for long-term sedation in mechanically ventilated ICU patients compared with propofol [10].

As an emerging drug, remimazolam has a relatively short history of clinical use. Current research on this drug is mainly concentrated in the fields of endoscopy and anesthesiology, with relatively few studies focusing on its sedative application in ICU patients. Therefore, the aim of this study was to evaluate the effect of ective, randomized controlled, pilot study was conducted to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210009
        • Reclutamento
        • Zhongda Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥ 18 years;
  • Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;
  • Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;
  • Informed consent obtained from the patient's family

Exclusion Criteria:

  • Body mass index (BMI) > 30 kg/m²
  • Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment
  • Mean arterial pressure (MAP) < 55 mmHg despite intravenous fluid resuscitation and vasopressors
  • Heart rate < 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker
  • Acute myocardial infarction or severe heart failure (New York Heart Association [NYHA] class IV)
  • Left ventricular ejection fraction < 30%
  • Any contraindication or allergy to benzodiazepines
  • Substance dependence, alcohol abuse, or psychiatric/psychological disorders. Alcohol abuse was defined as regular consumption of > 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor)
  • Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C)
  • Chronic kidney disease with a glomerular filtration rate (GFR) < 60 mL/min/1.73 m²
  • Neuromuscular disease
  • Patients on extracorporeal membrane oxygenation (ECMO)
  • Pregnancy or breastfeeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: propofol
In the control group, patients received propofol emulsion injection at a loading dose of 0.3 mg/kg/h injected over 1 min, followed by a continuous infusion at a rate of 0.3 mg/kg/h. Dose adjustments were made in increments of 0.3-0.6 mg/kg/h, within a dose range of 0.3-4 mg/kg/h, to achieve the target sedation level (RASS: -3 to 0).
Sperimentale: remimazolam
In the intervention group, patients with a Richmond Agitation-Sedation Scale (RASS) score of -3 to 0 were given remimazolam besylate for injection at a loading dose of 0.08 mg/kg infused intravenously over 10 min, followed by a continuous infusion at a rate of 0.2 mg/kg/h. When dose adjustment was required, each step was 0.1-0.2 mg/kg/h, with a dose range of 0-2 mg/kg/h, until the target sedation level (RASS: -3 to 0) was achieved. If the target sedation level was not reached, an additional bolus dose of 0.08 mg/kg remimazolam besylate could be administered.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
28-day ventilator-free days
Lasso di tempo: 28-day
28-day

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Mortalità a 28 giorni
Lasso di tempo: 28 giorni
28 giorni
Incidence of delirium
Lasso di tempo: Up to 28 days
Up to 28 days
28-day shock-free days
Lasso di tempo: 28-day
28-day
ICU length of stay
Lasso di tempo: Up to 30 days
Up to 30 days
hospital length of stay
Lasso di tempo: Up to 60 days
Up to 60 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2025

Completamento primario (Stimato)

31 gennaio 2027

Completamento dello studio (Stimato)

31 gennaio 2027

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2022ZDSYLL327-P01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Remimazolam

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