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50% effective dose ED50 of rimazolam toluenesulfonate for gastroscopic diagnosis and treatment in elderly patients

50% effective dose ED50 of rimazolam toluenesulfonate for gastroscopic diagnosis and treatment in elderly patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053463
Enrollment
Unknown
Registered
2021-11-22
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Gastroenteroscopic anesthesia

Interventions

Group A:Remazolam 0.2mg/Kg
Group B:Remazolam 0.25mg/Kg
Group C:Remazolam 0.3mg/Kg

Sponsors

Quanzhou First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 65 years, gender is not limited; 2. Patients receiving routine gastroscopic diagnosis and treatment; 3. ASA score is I-III; 4. BMI < 30kg/m^2; 5. Clearly understand and voluntarily participate in the research, and sign the informed consent form by myself.

Exclusion criteria

Exclusion criteria: 1. Complicated endoscopic diagnosis and treatment techniques are required (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.); 2. Patients with severe respiratory disease (obstructive sleep apnea syndrome, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.) or myasthenia gravis; 3. Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV); 4. Those who suffer from mental system diseases (schizophrenia, mania, insanity, etc.) and long-term use of psychotropic drugs and cognitive dysfunction; 5. Anemia or thrombocytopenia: Hb = 2.5 x ULN, TBIL >= 1.5 x ULN; 7. Abnormal renal function: urea or urea nitrogen >= 1.5 x ULN, serum creatinine is greater than the upper limit of normal; 8. History of drug abuse, drug abuse and alcohol abuse within 2 years before the start of the screening period. Alcohol abuse means drinking more than 2 units of alcohol on average per day (1 unit = 360mL of beer or 45mL of liquor with an alcohol content of 40% or 150mL of wine); 9. Patients who have not received regular antihypertensive treatment or have poor blood pressure control (sitting systolic blood pressure >= 160 mmHg or =100 mmHg during screening); 10. Taking benzodiazepines and/or opioids every day for one month or intermittently for the past three months; 11. Those who are allergic to or have contraindications to benzodiazepines, opioids, propofol and other drugs and their components; 12. Participated in any clinical trial as a subject within the past 3 months; 13. The researchers believe that patients should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Anesthetic effect;Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and blood oxygen saturation (SpO2);

Countries

China

Contacts

Public ContactSun Jiaxiao

Quanzhou First Hospital

leonkillua@163.com+86 15859491198

Outcome results

None listed

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