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Efficacy and safety of remazolam in general anesthesia induction in elderly patients: a single center, randomized, single blind, positive drug, paralleled, controlled study

Efficacy and safety of remazolam in general anesthesia induction in elderly patients: a single center, randomized, single blind, positive drug, paralleled, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047274
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-02-01

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

Conditions

The dose range of remazolam tosylate for induction and maintenance of general anesthesia in the elderly

Interventions

Experimental group1:In the induction period of the remazolam tosylate group, the administration rate was 6 mg/kg/h
Experimental group2:In the induction period of the remazolam tosylate group, the rate of administration was 12 mg/kg/h
Experimental group3:The loading dose of propofol during the induction period is 2.0-2.5 mg/kg

Sponsors

Dongguan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Subjects have a full understanding of the purpose and significance of this trial, volunteer to participate in this clinical trial, and sign an informed consent; 2. Patients who need general anesthesia for tracheal intubation for elective surgery; 3. Aged 60 to 80 years, Gender is not limited.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to remazolam tosylate, propofol, sufentanil and other pharmaceutical ingredients or components that may be used in the research; 2. Patients who have used narcotic analgesics, sedatives or non-steroidal anti-inflammatory drugs for a long time; 3. Opioid dependent or opioid tolerant; 4. Despite the use of vasoactive drugs, there are still patients with systemic hypotension; 5. Bradycardia, heart rate <55 beats/min; 6. High-level atrioventricular block without a pacemaker; 7. Combined with craniocerebral injury and intracranial hypertension; 8. Patients with severe heart, lung, liver, and kidney function abnormalities; 9. Those with a history of allergic diseases; 10. Those who have a history of mental illness; 11. Those with fat metabolism disorders; 12. Foreseeable difficult intubation; 13. The investigator judges that the subject is not suitable for other conditions in the clinical trial; patients with myasthenia gravis.

Design outcomes

Primary

MeasureTime frame
Anesthesia and sedation success rate;

Secondary

MeasureTime frame
Anesthesia induction time;Anesthesia recovery time;

Countries

China

Contacts

Public ContactXie Haihui

Dongguan People's Hospital

xhh900@163.com+86 13790588393

Outcome results

None listed

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