Skip to content

A study on safety and efficacy of remazolam toluenesulfonate in day surgery under general anesthesia

A study on safety and efficacy of remazolam toluenesulfonate in day surgery under general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047524
Enrollment
Unknown
Registered
2021-06-20
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

None

Interventions

Propofol group:Anesthesia induction: propofol 2.0-2.5mg /kg was slowly injected intravenously within 1 min
Anesthesia maintenance: The dosage of propofol was 4-10 mg/kg/h, and adjusted appropriately according to the general condition of the individual subject until the end of surgery
Remazolam toluenesulfonate group:nesthesia induction: intravenous injection of Remazolam toluenesulfonic 0.2-0.3mg /kg
Anesthesia maintenance: Remazolam toluenesulfonate was pumped intravenously at a dose of 0.5-1 mg/kg/h, adjusted according to the general condition of the individual subject (maximum allowable pumping

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1.Day surgery to be performed under endotracheal intubation under general anesthesia; 2.Aged 18 to 60 years; 3.American anesthesiologist grade (ASA) I or II; 4.18 kg/m^2 < BMI < 28 kg/m^2; 5.Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergy to benzodiazepines or with a previous history of severe allergy and a family history; 2.Long-term use of narcotic analgesics, sedatives or non-steroidal anti-inflammatory drugs; 3.Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis; 4.Unable to communicate due to severe dementia or language barrier before surgery; 5.Severe renal function impairment (requiring renal replacement therapy); Severe liver function impairment (Child-Pugh grade C); 6.Bradycardia, heart rate =90 min; 9.Vulnerable groups, including mental illness, critically ill patients, pregnant women, minors, cognitive impairment, etc..

Design outcomes

Primary

MeasureTime frame
sedative effectiveness;respiratory rate;haemodynamics;Intraoperative awakening or awareness;sedative remedy;limb activity;rimazolam dosage;arrhythmia;intraoperative infusion velocity changes and corresponding time points;recovery quality;other indicators;hepatorenal function;cognitive function;adverse event;pain, nausea and vomiting;satisfaction evaluation;

Countries

China

Contacts

Public ContactChen Gang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@zju.edu.cn+86 137 5711 8681

Outcome results

None listed

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