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

NCT07596589 | Recruiting Phase 3 DMC

• 1 other identifier: 2022ZDSYLL327-P01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Remimazolam Besylate; Mechanically Ventilated ICU Patients; Sedation

Keywords

remimazolam; sedation; ICU

Outcome Measures

Primary Outcomes (1)

• 28-day ventilator-free days

  28-day

Secondary Outcomes (5)

• Incidence of delirium

  Up to 28 days

• 28-day shock-free days

  28-day

• ICU length of stay

  Up to 30 days

• hospital length of stay

  Up to 60 days

• 28-day mortality

  28-day

Study Arms (2)

remimazolam

EXPERIMENTAL

Drug: Remimazolam

propofol

ACTIVE COMPARATOR

Drug: propofol

Interventions

Remimazolam DRUG

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.

remimazolam

propofol DRUG

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).

propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

00862583262500; xujingyuanmail@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)