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A single center, prospective, randomized, double-blind, controlled clinical study on the efficiency of anesthesia awakening in patients undergoing fundus surgery using remazolam besylate

A single center, prospective, randomized, double-blind, controlled clinical study on the efficiency of anesthesia awakening in patients undergoing fundus surgery using remazolam besylate

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079506
Enrollment
Unknown
Registered
2024-01-04
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

patients undergoing fundus surgery

Interventions

H group,:ciprofol
RF group:remimazolam+flumazenil

Sponsors

Sichuan Provincial People ' s Hospital , University of Electronic Science and Technology of China , Chengdu , China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) ASA I-II level, patients aged 18-65 years old; (2) Plan to undergo fundus surgery and choose general anesthesia; (3) Estimated surgical time of 30-120 minutes; (4) 18 < BMI < 30 kg/m2; (5) Sign an informed consent form and voluntarily participate in this experiment.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Patients with severe heart disease (heart function = grade 3, severe arrhythmia, etc.), severe chronic respiratory system disease, central nervous system disease, liver and kidney dysfunction, or unstable vital signs; (2) Previous adverse reactions to anesthetic drugs and lactose; (3) Have a history of abuse of psychotropic drugs within 3 months; (4) Long term alcoholism; (5) Long term use of immunosuppressive agents such as hormones or a history of adrenal cortex suppression; (6) Children and guardians refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
MOAA/S score;Aldrete score;time for wake up;

Secondary

MeasureTime frame
PSI;remimazolam;heart rate;

Countries

China

Contacts

Public ContactTing Xu

Sichuan Provincial People ' s Hospital , University of Electronic Science and Technology of China , Chengdu , China

rourou430@126.com+86 177 0813 0267

Outcome results

None listed

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