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A multicenter, randomized, controlled clinical study on the effectiveness and safety of remazolam tosylate for injection in general anesthesia in elderly patients

A multicenter, randomized, controlled clinical study on the effectiveness and safety of remazolam tosylate for injection in general anesthesia in elderly patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042281
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-01-04
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Anesthesia

Interventions

Remazolam tosylate group:Remazolam Tosylate for Injection

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) ASA score is I-III level, aged 18-60 years, regardless of gender; 2) Be sane before surgery; 3) It is planned to undergo elective abdominal laparoscopic surgery through outpatient admission to the hospital, and the expected operation time is 2-4 hours; 4) Volunteer to participate in this research and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Have a serious mental illness; 2) Patients with severe cardiopulmonary and vascular diseases can not tolerate surgery; 3) MMSE score was lower than 23 before operation; 4) A history of alcohol abuse, opioid allergy or drug abuse; 5) Emergency surgery; 6) Combined organ resection required; 7) Severe uncontrolled high blood pressure; 8) Researchers believe that any signs of severe or uncontrolled systemic disease that may significantly affect the patients risk/benefit balance, including paralysis, severe myocardial and cerebral infarction, severe spinal deformities, combined diseases that affect the prognosis and course of the disease, type B Hepatitis, hepatitis C, human immunodeficiency virus, etc; 9) Researchers believe that they are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting;

Secondary

MeasureTime frame
Incidence of postoperative delirium;Incidence of sleep disorders;

Countries

China

Contacts

Public ContactE Wang

Xiangya Hospital of Central South University

Ewang324@163.com+86 18874889950

Outcome results

None listed

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