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Clinical study on the effectiveness and safety of toluenesulfonate for the treatment of gastric mirror diagnosis in elderly patients

Clinical study on the effectiveness and safety of toluenesulfonate for the treatment of gastric mirror diagnosis in elderly patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046877
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

Group 1:Remiazolam benzenesulfonate 5mg + sufentanil 0.05~0.1ug/kg
Group 2:Remiazolam benzenesulfonate 0.15mg / kg / kg + sufentanil 0.05~0.1ug/kg
Group 3:Propofol 1mg hand kg + sufentanil 0.05ug/kg

Sponsors

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, no gender limit; 2. Patients receiving routine gastroscopy diagnosis and treatment; 3. The ASA score is I - III; 4. 18 kg/ m^2 < BMI < 30kg/m^2; 5. Patients clearly understand and voluntarily participate in the study, and sign an 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 who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV); 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
Sedation success rate;

Secondary

MeasureTime frame
Sedation induction time;Sedation and awakening time;Discharge time;Incidence of sedative hypotension;Incidence of respiratory depression during sedation;Satisfaction scores of anesthesiologists, endoscopists and patients;Incidence of sedative hypotension requiring treatment;

Countries

China

Contacts

Public ContactZou Xiaohua

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