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The median effective dose and 95% effective dose of Remimazolam Tosilate to inhibit the painless gastroscopy reaction in elderly patients of different age groups: an up-and-down sequential allocation trial

The median effective dose and 95% effective dose of Remimazolam Tosilate to inhibit the painless gastroscopy reaction in elderly patients of different age groups: an up-and-down sequential allocation trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062842
Enrollment
Unknown
Registered
2022-08-20
Start date
2022-08-20
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

None listed

Interventions

A:elderly patients between 65 and 74 years old
B:elderly patients >= 75 years old

Sponsors

The Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 65 years, male and female; 2. Patients scheduled for gastroscopy; 3. ASA grade I-III; 4. 18 kg/? < BMI < 30 kg/?; 5. Patients clearly understand and voluntarily participate in the study, and sign the informed consent form by themselves.

Exclusion criteria

Exclusion criteria: 1. Patients who intend to undergo tracheal intubation (including laryngeal mask); 2. Acute heart failure, unstable angina, myocardial infarction occurred within 6 months before screening, resting ECG heart rate = 450 ms, female >= 470 ms; 3. Patients suffering from severe respiratory disease (obstructive sleep apnea syndrome, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 4. Patients suffering from mental system diseases (schizophrenia, mania, bipolar disorder, confusion, etc.) and long-term use of psychiatric drugs and cognitive dysfunction; 5. Patients with expected difficult airway; 6. Anemia or thrombocytopenia: Hb = 160 mmHg or = 100 mmHg during the screening period); 9. Those who are allergic or contraindicated to benzodiazepines, opioids and other drugs and their drug components; 10. Participated in other drug clinical trials as subjects in the past 3 months; 11. The investigator believes that it is not appropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
50% effective dose (ED50);95% effective dose (ED95);

Secondary

MeasureTime frame
Success rate of sedation;Incidence of Hypotension;Incidence of respiratory depression;Sedation induction time;Incidence rate of nausea and vomiting;Incidence of injection pain;Incidence of Arrhythmias;

Countries

China

Contacts

Public ContactXiaohua Zou

The Affiliated Hospital of Guizhou Medical University

562931613@qq.com+86 13809416063

Outcome results

None listed

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