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The Efficacy and Safety of Remimazolam Tosilate for Injection in the General Anesthesia: a Randomized, Single Blind, Parallel Controlled Study

The Efficacy and Safety of Remimazolam Tosilate for Injection in the General Anesthesia: a Randomized, Single Blind, Parallel Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034031
Enrollment
Unknown
Registered
2020-06-21
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

General anesthesia patients

Interventions

Group 1:Remimazolam Tosilate for Injection
Group 2:propofol

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) 18 <= age <= 65, gender unlimited; 2) The operation time was less than 2 hours; 3) ASA score is grade I or II; 4) 18 kg/m2 < BMI < 30kg/m2; 5) Clearly understand and voluntarily participate in the study, and sign the informed consent form by himself / herself.

Exclusion criteria

Exclusion criteria: 1) Keywords emergency operation; hypovolemia, shock or coma; 2) Besides general intravenous anesthesia, other anesthesia methods should be combined, such as inhalation anesthesia, epidural anesthesia and subarachnoid anesthesia; 3) Keywords infective heart disease such as myocarditis or endocarditis; sepsis; 4) Uncontrolled hypertension, diabetes, heart failure, etc.; 5) Abnormal liver function, AST and / or ALT >= 2.5 * ULN, TBIL >= 1.5 * ULN; 6) Renal function was abnormal, urea or urea nitrogen >= 1.5 * ULN, creatinine was higher than the upper limit of normal value; 7) Patients with mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and long-term history of taking psychotropic drugs and cognitive dysfunction; 8) Pregnant or lactating women; 9) Allergic or contraindicated to benzodiazepines, opioids, propofol, muscle pines and other drugs; 10) Other circumstances in which the researchers consider it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia and sedation;

Secondary

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

Countries

China

Contacts

Public ContactXiaobao Zhang

Department of Anesthesiology, the First People's Hospital of Lianyungang

hotdog100@163.com+86 18961322507

Outcome results

None listed

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