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Randomized controlled study of efficacy and safety of remimazzolam tosylate combined with propofol for sedation in gastroscopy diagnosis and treatment of elderly patients

Randomized controlled study of efficacy and safety of remimazzolam tosylate combined with propofol for sedation in gastroscopy diagnosis and treatment of elderly patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063700
Enrollment
Unknown
Registered
2022-09-15
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Routine painless gastroscopy

Interventions

Group R1:0.1mg/kg remimazzolam tosylate+propofol 0.5mg/kg, and propofol 0.5mg/kg/ time as needed.
Group R2:0.15mg/kg rimazolam tosylate+propofol 0.5mg/kg, and propofol 0.5mg/kg/ time as needed.
Group P:Propofol 1.5mg/kg, IV 1min, and propofol 0.5mg/kg/ time as needed.

Sponsors

The Third Xiangya 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, gender is not limited; 2)Patients receiving routine gastroscopy treatment; 3)ASA scores I to III; 4)18 kg/m2<BMI<30kg/m2; 5)The gastroscope operation time is expected to be less than 30min; 6)Understand and voluntarily participate in the research, and sign the informed consent form by himself.

Exclusion criteria

Exclusion criteria: 1)Patients with mental and psychological diseases and nervous system diseases; 2)Patients who take antipsychotic drugs such as diazepam and anti-anxiety, and who drink or abuse drugs; 3)Patients with language communication, vision or hearing impairment; 4)Complex endoscopic diagnosis and treatment techniques are required (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.); 5)Patients to be intubated; It is judged as a patient with respiratory tract management difficulty (modified Mallampati score is grade IV); 6)Hypertensive patients whose blood pressure is not satisfactorily controlled by antihypertensive drugs (sitting systolic pressure ?160mmHg in screening period and/or diastolic pressure ?100mmHg in screening period); 7)SBP Grade 2, basic SpO2<92%); 10)Severe liver damage; 11) Severe renal impairment; 12)Allergic or contraindicated to benzodiazepines, propofol and their pharmaceutical components; 13)In the past 3 months, as a subject, he has participated in clinical trials of ramizolam or other drugs; 14)The researcher thinks that it is inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Cardiopulmonary adverse events;

Secondary

MeasureTime frame
Changes of perioperative cognitive function;

Countries

China

Contacts

Public ContactWen Ouyang
ouyangwen139@126.com13974934441

Outcome results

None listed

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