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Efficacy and safety of remimazolam tosilate for sedation during noninvasive ventilation in patients with acute respiratory failure: a randomized, double-blind, midazolam controlled study

Efficacy and safety of remimazolam tosilate for sedation during noninvasive ventilation in patients with acute respiratory failure: a randomized, double-blind, midazolam controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043930
Enrollment
Unknown
Registered
2021-03-05
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory failure

Interventions

treatment group:Sedation with remimazolam tosilate
control group:Sedation with midazolam

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Above the age of 18 years old, blood gas analysis suggested that Pao2 < 60 mmhg, or Pao2/Fio2 < 200 mmhg, could not continue to receive non-invasive ventilation due to mask intolerance.

Exclusion criteria

Exclusion criteria: 1. Immediate intubation is required (PH = 85 years; 3. Severe hypotension (Mean Arterial Pressure = 4); 7. Liver failure (in accordance with the 2012 edition of the Guidelines for the Diagnosis and Treatment of Liver Failure); 8. Renal failure(diagnosed according to 2012 KDIGO clinical practice guideline for the evaluation and management of Chronic Renal Disease and Acute Renal Injury); 9. Upper gastrointestinal bleeding, perforation, obstruction; 10. Severe disturbance of consciousness (GCS < 12 points); 11. Refused to accept invasive or non-invasive mechanical ventilation by family members.

Design outcomes

Primary

MeasureTime frame
RSAS score;

Secondary

MeasureTime frame
the time when the RSAS score reached the target sedation level during non-invasive ventilation, the incidence of excessive sedation (RSAS 4), heart rate, blood pressure, respiratory frequency and arterial blood gas at each patient observation time point;

Countries

China

Contacts

Public ContactChangyong Wang

Department of Critical Care Medicine, Renmin Hospital of Wuhan University

wcywhu@sina.com+86 13697328672

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026