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Observation study on the efficacy and safety of tolansulfonic acid remimazolam in induction and maintenance therapy regimens in adult surgery

Observation study on the efficacy and safety of tolansulfonic acid remimazolam in induction and maintenance therapy regimens in adult surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122664
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

None

Interventions

Remimazolam group:Anesthesia induction with Remimazolam Tosilate (0.2-0.3 mg/kg, intravenous injection) and maintenance by continuous infusion (at a rate of 0.2-3.0 mg/kg/h), combined with Sufentanil
Propofol group:Anesthesia induction with Propofol (1.5-2.5 mg/kg, intravenous injection) and maintenance by continuous infusion (at a rate of 2-5 mg/kg/h), combined with Sufentanil and Cisatracurium (

Sponsors

Shaoxing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-65 years; 2. American Society of Anesthesiologists (ASA) classification I-III; 3. Planned elective surgery, with an expected duration of 1-6 hours; 4. Patients and their families have signed informed consent and voluntarily agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to benzodiazepines; 2. Those with severe liver or kidney dysfunction (e.g., serum alanine aminotransferase or aspartate aminotransferase exceeding three times the upper limit of normal, creatinine clearance below 50 ml/min); 3. Those with severe cardiovascular diseases (e.g., unstable angina, acute myocardial infarction, severe arrhythmia, NYHA class III or higher heart failure); 4. Those with mental illness or cognitive dysfunction who cannot cooperate with the researchers; 5. Those who have recently (within 3 months) used drugs affecting the central nervous system, such as antidepressants, antiepileptics, etc.

Design outcomes

Primary

MeasureTime frame
incidence of postoperative nausea and vomiting (PONV);

Secondary

MeasureTime frame
perioperative adverse reactions;Hepatic and renal function indices (including Alanine Aminotransaminase [ALT], Aspartate Aminotransaminase [AST], Total Bilirubin [TBIL], Direct Bilirubin [DBIL], Creatinine [Cr], and Blood Urea Nitrogen [BUN]);Coagulation profile (including Prothrombin Time [PT], Activated Partial Thromboplastin Time [APTT], Fibrinogen [FIB], and Platelet Count [PLT]);time to loss of eyelash reflex;BIS values at various time points after drug administration;intraoperative movement response;extubation time;PACU length of stay;VAS score (after extubation);Patient satisfaction with sedation score (1-5 points);Surgeon’s satisfaction with sedation score (1-5 points);perioperative vital signs;QOR-15 score on postoperative day 1;perioperative medication administration;

Countries

China

Contacts

Public ContactZhonghua Chen

Shaoxing People's Hospital

chenbeijing116@163.com+86 136 2575 1526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026