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A comparison of Remimazolam Tosilate versus Propofol on intraoperative stability of hemodynamics in patients undergoing endoscopic submucosal dissection

A comparison of Remimazolam Tosilate versus Propofol on intraoperative stability of hemodynamics in patients undergoing endoscopic submucosal dissection: A randomized, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037975
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-09-20
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Intraoperative hemodynamics

Interventions

Sponsors

Department of Anesthesiology, Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years, regardless of gender; 2. Patients to be treated by endoscopic submucosal dissection; 3. Patients with ASA grade I ~ III; 4. Patients with 18 kg / m2 < BMI < 30 kg / m2; 5. Clearly understand the patients who voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe respiratory diseases (obstructive sleep apnea syndrome, acute respiratory tract infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, active massive hemoptysis, severe pulmonary hypertension, etc.); 2. Patients undergoing emergency surgery; hypovolemia, shock or coma; 3. Patients with acute heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; 4. Patients with resting ECG heart rate less than 50 beats / min; third degree atrioventricular block; severe arrhythmia; moderate and severe heart valve disease; 5. Patients with infectious heart diseases such as myocarditis, endocarditis and sepsis; 6. 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; 7. Patients with abnormal coagulation function: (PT > ULN + 3S and / or APTT > ULN + 10s); anemia or thrombocytopenia: HB ULN + 3S and APTT > ULN + 10s; 8. Patients with abnormal liver function: AST and / or ALT >= 2.5 x ULN, TBIL >= 1.5 x ULN; 9. Patients with abnormal renal function: urea or urea nitrogen >= 1.5 x ULN, serum creatinine higher than the upper limit of normal value; 10. Patients with drug abuse history, drug abuse history and alcohol abuse history within 2 years before the start of screening period (average drinking more than 2 units of alcohol, 1 unit = 360ml beer or 45ml liquor with 40% alcohol volume or 150ml wine); 11. Patients without regular antihypertensive treatment or poor blood pressure control (SBP >= 160mmhg or = 100 mmhg during screening period); 12. Patients whose blood glucose was not controlled satisfactorily (random blood glucose >= 11.1 mmol / L during screening period); 13. Allergic or contraindicated to benzodiazepines, opioids, propofol and other drugs and their components; 14. Patients with difficult airway (modified Mahalanobis grade IV); 15. Pregnant or lactating women; patients with family planning within 3 months (including men); 16. Patients considered unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative hypotension;

Secondary

MeasureTime frame
Parameters of Hemodynamic;

Countries

China

Contacts

Public ContactJingxiang Wu

Shanghai Chest Hospital

wjx1132@163.com+86 18930857186

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026