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Comparative Study of Different Doses of Remazolam Toluene Sulfonate for Injection in Anesthesia for General Surgery: a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Trial

Comparative Study of Different Doses of Remazolam Toluene Sulfonate for Injection in Anesthesia for General Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038094
Enrollment
Unknown
Registered
2020-09-10
Start date
2020-11-30
Completion date
Unknown
Last updated
2020-11-24

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

Conditions

General anesthesia

Interventions

Remazolam tosylate low dose group (Group A):Anesthesia induced intravenous injection of remazzolam tosylate at a dose of 0.1mg/kg (1 min)
Remazolam tosylate medium dose group (Group B):Anesthesia induced intravenous injection of remazzolam tosylate at a dose of 0.15mg/kg (1 min)
Remazolam tosylate high dose group (group C):Anesthesia induced intravenous injection of remazzolam tosylate at a dose of 0.2mg/kg (1 min)
Propofol Group (Group D):Propofol 2mg/kg was used for anesthesia induction

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 <= age <= 60 years old, regardless of gender; 2) Patients undergoing elective short surgery under general anesthesia; 3) ASA score is Grade I or Grade II; 4) 18kg/m2 < BMI < 30kg/m2 5) Clearly understand and voluntarily participate in the research, and sign the informed consent form by himself.

Exclusion criteria

Exclusion criteria: 1) Patients undergoing endotracheal intubation; 2) Patients with difficult airway; 3) anemia or thrombocytopenia, HB = 2.5 x ULN, TBIL >= 1.5 x ULN; 5) Abnormal renal function, serum creatinine greater than the normal upper limit; 6) Hypertensive patients whose blood pressure is not satisfactorily controlled by antihypertensive drugs (systolic blood pressure >= 160mmHg, and/or diastolic blood pressure >= 100 mmHg); 7) systolic blood pressure <= 90 mmHg; 8) Women during pregnancy or lactation; 9) Patients allergic to benzodiazepines and opioids; 10) Participated in clinical trials of other drugs as subjects in recent 3 months; 11) patients who are considered unsuitable by researchers to participate in this test or who refuse to do so by themselves; 12) people with mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.), long-term history of taking psychotropic drugs and cognitive dysfunction;

Design outcomes

Primary

MeasureTime frame
Consciousness vanishing time;Withdrawal time;

Secondary

MeasureTime frame
Hemodynamic influence of patients;Sedative Allen Su time;PACU residence time;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactJiang Ji-Duan

Suining Central Hospital of Sichuan Province

623663239@qq.com+86 18728581192

Outcome results

None listed

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