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Real-world study of the quality of recovery from general anesthesia using Remimazolam Tosilate Injection

A multicenter, prospective, non-interventional study of Remimazolam tosilate for injection in the real-world for recovery quality after general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114179
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-01-14
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Adult surgical patients

Interventions

Remimazolam Tosilate:None

Sponsors

Xiangya Hospital Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients receiving Remimazolam Tosilate injection for the maintenance of general anesthesia in non-cardiac surgery; 2.Patients aged >=18 years old, and with an ASA classification of <=3; 3.Patients must sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who are participating in or planning to participate in any interventional clinical trials; 2.Patients who are allergic to any components of benzodiazepines or Remimazolam Tosilate; 3.Patients with severe depressive states, schizophrenia, or myasthenia gravis; 4.Patients who are expected to require postoperative admission to the ICU or continuous mechanical ventilation; 5.Patients whom the investigator deems unsuitable for this study for any other reason.

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse Events (AEs) during the PACU period: The composite endpoint consists of emergence nausea and vomiting, emergence hypoxemia, and emergence hypotension;

Secondary

MeasureTime frame
Incidence of Emergence Nausea and Vomiting;Time to meet discharge criteria;Incidence of Emergence Hypoxemia;Incidence of nausea and vomiting within 24 hours after surgery;QoR-15 scores on postoperative day 1 and day 3;Time of extubation;Incidence of Emergence Delirium and Postoperative Delirium;Incidence of Emergence Hypotension;Anesthesia Recovery Time;Incidence of Hypotension During Anesthesia Maintenance;

Countries

China

Contacts

Public ContactE Wang

Xiangya Hospital Central South University

EWANG324@163.COM+86 731 84327413

Outcome results

None listed

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