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Efficacy and safety of remimazolam tosilate in obese patients undergoing mechanical ventilation: a single-center randomized, controlled study

Efficacy and safety of remimazolam tosilate in obese patients undergoing mechanical ventilation: a single-center randomized, controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089339
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-16
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Obese patients requiring mechanical ventilation

Interventions

Experimental group:Remimazolam tosilate (RMZ Rebening @, Jiangsu Hengrui Pharmaceutical Co., LTD., Chinese Medicine approval number H20190034, 36mg/ dose) was used for sedation, and remimazolam was co
Control group:Propofol (LWJ Leweijing@, Sichuan Guorui Pharmaceutical Co., LTD., Chinese Medicine approval number H20030115, 0.5g/ branch) was continuously pumped intravenously at an initial infusion

Sponsors

Dazhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age =18 years old; BMI =30kg/m2; The duration of tracheal intubation before enrollment was =24 hours, and it was expected that mechanical ventilation and sedation were still needed for =96 hours. Hemodynamic stability, mean arterial pressure (MAP) =65mmHg; No sedative drugs such as remimazolam tosilate were used before the experiment. Before enrollment, analgesic and sedative drugs were stopped for drug washout.

Exclusion criteria

Exclusion criteria: Women who are pregnant or lactating; Severe hemodynamic instability; Patients with abnormal heart rhythm; Patients with disturbance of consciousness or unable to complete the assessment of analgesia and sedation; Cervical spine and spinal injuries; Acute hepatitis or severe liver dysfunction (Child-Pugh class C); Severe chronic kidney disease (glomerular filtration rate < 60 ml/min/1.73m2); Alcoholism;

Design outcomes

Primary

MeasureTime frame
Hemodynamic changes during sedation;Success rate of sedation;Refers to oxygen saturation (SpO2);Oxygenation index (PO2/FiO2);

Secondary

MeasureTime frame
Duration of mechanical ventilation;Length of ICU stay;Average daily cost of sedatives;The dose of sedative drugs was calculated;28-day mortality;

Countries

China

Contacts

Public ContactCheng Liu

Dazhou Central Hospital

729599764@qq.com+86 150 8242 8283

Outcome results

None listed

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