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Randomized controlled study on the efficacy and safety of remiazolam mesylate injection combined with propofol for sedation in elderly patients undergoing gastroscopy

Randomized controlled study on the efficacy and safety of remiazolam mesylate injection combined with propofol for sedation in elderly patients undergoing gastroscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065648
Enrollment
Unknown
Registered
2022-11-10
Start date
2022-10-27
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Metabolic disease

Interventions

R1 group:0.1 mg/kg Remazolam Toluenesulfonate+0.5 mg/kg Propofol, add 0.5 mg/kg Propofol as needed
R2 group:0.15 mg/kg Remazolam Toluenesulfonate+0.5 mg/kg Propofol, add 0.5 mg/kg Propofol as needed
P group:Propofol 1.5mg/kg, IV for 1min, add propofol as needed, 0.5mg/kg/time

Sponsors

Xiangya III Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 65 <= age <= 75 years old, regardless of gender; 2. Patients receiving routine gastroscopy; 3. ASA scores from I to III; 4. 18 kg/m^2<BMI<30kg/m^2; 5. It is estimated that the operation time of gastroscope shall not exceed 30min; 6. Clearly understand, voluntarily participate in the study, and sign the informed consent form by himself.

Exclusion criteria

Exclusion criteria: Patients with any of the following cannot be included in this study: 1. Patients with psychosocial diseases and nervous system diseases; 2. Patients who take antipsychotic drugs such as tranquilizer and antianxiety, and who drink or abuse drugs; 3. Patients with language communication, vision or hearing impairment; 4. Complex endoscopic diagnosis and treatment technologies (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myotomy, etc.) are required; 5. Patients to be intubated; The patient was judged as having difficulty in managing respiratory tract (the modified Markovian score was Grade IV); 6. Hypertension patients whose blood pressure was not controlled satisfactorily after antihypertensive drug treatment (sitting systolic blood pressure >= 160mmHg, and/or diastolic blood pressure >= 100mmHg in screening period); 7. SBP2, basic SpO2<92%); 10. Severe liver function damage; 11. Severe renal function damage; 12. Allergies to or contraindications to benzodiazepines, propofol, and their drug components; 13. Participated in clinical trials of Remazolam or other drugs as a subject in recent 3 months.

Design outcomes

Primary

MeasureTime frame
Cardiopulmonary adverse events;

Countries

China

Contacts

Public ContactZhiping Wang

Affiliated Hospital of Xuzhou Medical University

zhpsqxt@126.com+86 13338787071

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026