The amnesia effect of Remimazolam Besylate in audlt undergoing general anesthesia: a randomized controlled, double-blind trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076172

Enrollment

Unknown

Registered

2023-09-26

Start date

2023-09-26

Completion date

Unknown

Last updated

2023-10-03

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

Conditions

None listed

Interventions

Remimazolam Besylate:Continuous intravenous pumping Remimazolam Besylate (0.1mg/kg/min)

Propofol:Continuous intravenous pumping Remimazolam Besylate (0.1mg/kg/min)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. ASAI-II; 2. selective painless gastroscopy; 3. Aged 18 to 60 years 4. BMI18.5~23.9; 5. Voluntary participation in the trial and signing of the informed consent statement;

Exclusion criteria

Exclusion criteria: 1. Patients with mental illness or cognitive dysfunction; 2. Using sedative drugs during Screening Period; 3. History of difficult airway diseases or possibility like OSAS ,etc; 4. History of allergy to the drug studied; 5. Voluntary participation do not agree to either sign of the informed consent statement or follow the research protocol ; 6. Pregnantwoman or lactating women;

Design outcomes

Primary

Measure	Time frame
the incidence of complete anterograde amnesia;	—

Secondary

Measure	Time frame
the incidence of complete retrograde amnesia;the incidence of incomplete anterograde amnesia;the incidence of incomplete retrograde amnesia;The time of first recovering consciousness;Modified observer’s assessment of alert;Dosage of Propofol during the operation;The time of anesthesia resuscitation;The time of MOAA/s first reaching 5 points;The residence time of patient in Post-anesthesia Care Unit;Heart rate;Blood pressure;Pulse saturation;	—

Measure

Time frame

the incidence of complete retrograde amnesia;the incidence of incomplete anterograde amnesia;the incidence of incomplete retrograde amnesia;The time of first recovering consciousness;Modified observer’s assessment of alert;Dosage of Propofol during the operation;The time of anesthesia resuscitation;The time of MOAA/s first reaching 5 points;The residence time of patient in Post-anesthesia Care Unit;Heart rate;Blood pressure;Pulse saturation;

—

Countries

China

Contacts

Public ContactHan Lin

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

nanlinhannansh@qq.com+86 158 6871 0831

Outcome results