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Efficacy and safety of remidazolam versus propofol for sedation in ICU postoperative patients: a randomized, controlled, multicenter clinical study

Efficacy and safety of remidazolam versus propofol for sedation in ICU postoperative patients: a randomized, controlled, multicenter clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047826
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-06-14
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Patients with mechanical ventilation and need sedation after ICU operation

Interventions

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years, male or female; 2. Transfer to ICU after operation; 3. Tracheal intubation or tracheotomy and mechanical ventilation are required, and ventilation and sedation are expected to be required for at least 6 hours after randomization; 4. Sedation needs are mild to moderate sedation; 5. The subject himself or his legal representative agrees and signs a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with myasthenia gravis, schizophrenia, severe dementia, and severe depression in the past; 2. Those who are allergic to benzodiazepines or propofol in the past; 3. Those with preoperative ASA (American Society of Anesthesiologists) grade II or above (grade I: healthy body, good development and nutrition, normal function of various organs; grade II: mild comorbidities except surgical diseases, and functional compensation is sound , no parenchymal organ function limitation; grade III: severe coexisting disease, limited physical activity, but still able to cope with daily activities, that is, parenchymal organ function limitation, combined with one or more moderate to severe diseases; grade IV: combined severe Illness, loss of daily activities, and often life-threatening; Class V: a dying patient, with no possibility of survival without surgery; Class VI: a patient declared brain-dead, ready to be used as a donor for organ removal and transplantation); 4. Those who are pregnant or breastfeeding; 5. Those who are deemed inappropriate by the investigator to participate in the trial.

Design outcomes

Secondary

MeasureTime frame
Efficacy index;

Countries

China

Contacts

Public ContactPeng Zhiyong

Zhongnan Hospital of Wuhan University

pengzy5@hotmail.com+86 18672396028

Outcome results

None listed

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