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Study on the effectiveness and safety of Remimazolam Tosilate for Injection in general anesthesia during day surgery: a prospective, randomized, double-blind, double-simulation, parallel controlled clinical trial

Study on the effectiveness and safety of Remimazolam Tosilate for Injection in general anesthesia during day surgery: a prospective, randomized, double-blind, double-simulation, parallel controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037877
Enrollment
Unknown
Registered
2020-09-03
Start date
2020-09-07
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

General anesthesia for day surgery

Interventions

Trial group:Remazolam tosylate and fat emulsion for injection are used for intravenous induction, and remazolam tosylate, fat emulsion and remifentanil for injection are used for intravenous maintenan
Control group:Equipped with saline, propofol for intravenous induction, saline, propofol, and remifentanil for intravenous maintenance

Sponsors

The First People's Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with 18 <= age < 65 years old, regardless of gender; 2. The operation time was less than 2 hours in patients with selective operation; 3. Patients with ASA grade I or II; 4. Patients with 18 kg / m2 < BMI < 30 kg / m2; 5. Clearly understand and voluntarily participate in the study, and their informed consent form is signed by themselves.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing emergency surgery; hypovolemia, shock or coma; 2. Patients who need other anesthesia besides general intravenous anesthesia, such as inhalation anesthesia, epidural anesthesia, subarachnoid anesthesia, etc; 3. Patients with infectious heart diseases, such as myocarditis or endocarditis; sepsis; and; 4. Patients with uncontrolled hypertension, diabetes, heart failure, etc; 5. In patients with abnormal liver function, AST and / or ALT >= 2.5 x ULN, TBIL >=1.5 x ULN; 6. In patients with abnormal renal function, urea or urea nitrogen >= 1.5 x ULN and serum creatinine higher than the upper limit of normal value; 7. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and those with long-term history of taking psychotropic drugs and cognitive dysfunction; 8. Pregnant or lactating women; 9. Patients with allergies or contraindications to benzodiazepines, opioids, propofol, muscle relaxants and their components; 10. Other situations in which the researcher considers it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Anesthesia and sedation success rate;

Secondary

MeasureTime frame
Incidence of hypotension during induction of anesthesia;Anesthesia recovery time;Incidence of intraoperative awareness;

Countries

China

Contacts

Public ContactZhao Zhibin

The First People's Hospital of Lianyungang

lygzhaozhibin@163.com+86 18961326661

Outcome results

None listed

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