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Clinical study of rimimazolam tosilate on postoperative cognitive dysfunction in patients undergoing knee surgery

Clinical study of rimimazolam tosilate on postoperative cognitive dysfunction in patients undergoing knee surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046613
Enrollment
Unknown
Registered
2021-05-23
Start date
2021-09-20
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

postoperative cognitive dysfunction

Interventions

experimental group 1:rimimazolam tosilate 0.1mg/kg
experimental group 2:rimimazolam tosilate 0.2mg/kg
experimental group 3:rimimazolam tosilate 0.3mg/kg
control group:???? 0.2mg

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, gender unlimited. 2 ASA grade was I – III. 3. 18 kg / m2 <= BMI <= 28 kg / m2. 4. General anesthesia patients receiving unilateral knee surgery. 5. Patients voluntarily participated in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic or taboo to benzodiazepines, opioids, propofol, flumazene, naloxone and their drug components. 2. Acute heart failure. Unstable angina. Myocardial infarction occurred within 6 months before screening. Resting ECG heart rate = 160 mmHg or SBP <= 90 mmHg in the screening period ). 5. Patients with obvious abnormal liver and kidney functions. 6. Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history and central nervous system diseases. 7. Patients with mental system diseases and long-term history of taking psychotropic drugs and cognitive dysfunction. 8. Patients who participated in any clinical trial within three months before selection. 9. Other conditions that are not suitable for inclusion are determined by researchers.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative cognitive dysfunction;

Countries

China

Contacts

Public ContactGong Taowu

The Affiliated Hospital of Zunyi Medical University

297486547@qq.com+86 15186687552

Outcome results

None listed

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