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Clinical study on efficacy and safety of different dose remimazolam in elderly patients during general anesthesia induction

Clinical study on efficacy and safety of different dose remimazolam in elderly patients during general anesthesia induction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047794
Enrollment
Unknown
Registered
2021-06-26
Start date
2021-06-28
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

General Anesthesia

Interventions

Four doses groups:remimazolam and propofol

Sponsors

Linfen Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.ASA i-ii; 2.Aged 60 to 80 years,no gender limitation; 3.18 kg/m2<=BMI<=30 kg/m2; 4.Voluntary participation in the study and the informed consent signed by the applicant or his legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to General Anesthesia; 2. There were significant preoperative breath, circulation dysfunction, liver kidney failure, anemia (HB 80< g/l) , Thrombocytopenia(PLT<80 x 10^9/L); 3. Patients with severe neuropsychiatric diseases; 4. Taking benzodiazepine or opioid drugs intermittently for a period of 1 month or for a period of nearly 3 months; 5. Hypersensitivity or contraindication to Benzodiazepine, opioids, propofol, flumazenil, naloxone and other drugs and their components; 6. Assessment of difficult airway (modified Markovian rating scale iv) ; 7. Patients who are participating in other clinical trials; 8. Researchers believe that other reasons are not appropriate for clinical trials.

Design outcomes

Primary

MeasureTime frame
Time from induction of anesthesia to BIS =60;diastolic blood pressure;

Secondary

MeasureTime frame
Changes in bispectralindex values over time;Number of remedial treatment cases;Number of cases of using antagonistic drugs;systolic blood pressure;heart rate;

Countries

China

Contacts

Public ContactWang Zhiguo

Linfen Central Hospital

1102265034@qq.com+86 17703579261

Outcome results

None listed

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