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Efficacy and safety of remimazolam tosilate for sedation in elderly patients undergoing gastroscopy: A multi-center prospective randomized controlled trial

Efficacy and safety of remimazolam tosilate for sedation in elderly patients undergoing gastroscopy: A multi-center prospective randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059332
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

None

Interventions

Propofol group:Propofol 1.5mg/kg + Sufentanil 0.1ug/kg
Remimazolam group:Remimazolam tosilate 0.2mg/kg + Sufentanil 0.1ug/kg

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/m^2 < BMI < 30kg/m^2; 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 = 450ms, female >= 470ms; 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, propofol 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
Incidence of respiratory depression;

Secondary

MeasureTime frame
Sedation induction time;Sedation success rate;Incidence of sedative hypotension;Incidence of sedative hypotension requiring treatment;Sedative recovery time;Discharge time;Satisfaction scores of anesthesiologists, endoscopists and patients;Incidence of adverse events;

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