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Clinical Study on the Comparison of Sedative Effects and Adverse Reactions of Remimazolam and Sequential Sedation in ICU Mechanically Ventilated Patients

Clinical Study on the Comparison of Sedative Effects and Adverse Reactions of Remimazolam and Sequential Sedation in ICU Mechanically Ventilated Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111017
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Sedation and analgesia for patients with mechanical ventilation

Interventions

Midazolam–Propofol Sequential Group:Sedation induction: Intravenous injection of midazolam 0.06 mg/kg–0.10 mg/kg
maintenance medication: adjust the micro-infusion pump for continuous intravenous infusion of midazolam 0.05 mg/(kg·h)–0.15 mg/(kg·h)
4 hours before discontinuation: switch to continuous intravenous infusion of propofol via micro-infusion pump 1 mg/(kg·h)–4 mg/(kg·h)
Midazolam — Dexmedetomidine group:Sedation induction: Intravenous injection of midazolam 0.06 mg/kg to 0.10 mg/kg
Maintenance medication: Continuous intravenous infusion of midazolam 0.05 mg/(kg·h) to 0.15 mg/(kg·h). Medication 4 hours before discontinuation: Switch to continuous intravenous infusion of dexmedeto
Remimazolam group:Sedation induction: Intravenous injection of remimazolam 0.1-0.2 mg/kg
Maintenance: Continuous intravenous infusion of remimazolam 0.1-0.3 mg/kg/h using a micropump
Medication 4 hours before discontinuation: No special adjustment.

Sponsors

Tongling People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All are ICU patients and meet the indications for mechanical ventilation, with an expected mechanical ventilation duration of more than 72 hours, and are over 18 years old.

Exclusion criteria

Exclusion criteria: 1. Allergy to sedative and analgesic drugs; 2. Suspected pregnancy; 3. Significant obesity with BMI greater than or equal to 30; 4. Extremely unstable circulatory system, for example, systolic blood pressure remains below 90 mmHg before starting the study drug infusion despite 30 ml/kg fluid resuscitation and continuous vasopressor infusion; 5. Uncontrolled severe hypertension, such as systolic blood pressure above 180 mmHg or diastolic blood pressure above 105 mmHg; 6. Heart rate below 50 beats per minute; 7. Second-degree or third-degree atrioventricular block; 8. Critical, moribund condition; 9. History of alcohol dependence or taking anti-anxiety or hypnotic drugs; 10. Chronic renal failure; 11. Traumatic brain injury, neurosurgery, or coma or seizure of unknown cause; 12. History of neuromuscular disease; 13. Patient or authorized representative unwilling to provide informed consent after admission to the ICU.

Design outcomes

Primary

MeasureTime frame
Offline time;

Secondary

MeasureTime frame
Sedation time (time from cessation of sedation to recovery of consciousness);Complications in ICU;Circulation index;Extubation time (time from sedation cessation to extubation);Proportion of time the RASS score is within the target sedation range;ICU hospitalization duration;Adverse event;

Countries

China

Contacts

Public ContactLi Fei

Tongling People's Hospital

m18256205120@163.com+86 182 5620 5120

Outcome results

None listed

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