A prospective clinical study to determine the extent of amnesia with different doses of remimazolam as an adjunctive sedative

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084233

Enrollment

Unknown

Registered

2024-05-13

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Amnesia

Interventions

Group 1:Remimazolam tosylate 0.05mg/kg

Group 2:Remimazolam tosylate 0.075mg/kg

Group 3:Remimazolam tosylate 0.1mg/kg

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.American Society of Anesthesiologists (ASA) physical status I to III; 2.Patients must provide written informed consent of their own free will; 3.18 years old = Age = 85 years old; 4.Patients scheduled for thoracoscopic surgery under general anesthesia;

Exclusion criteria

Exclusion criteria: 1.American Society of Anesthesiologists (ASA) physical status IV or above; 2.Patients with remimazolam induced or maintained anesthesia; 3.Patients with cognitive dysfunction before surgery (Mini-Mental Status Examination (MMSE450 ms for males, >470 ms for females; body mass index (BMI) > for > 470 ms37kg/m2; 6.Severe disease of the renal system; Severe liver system disease; 7.Patients judged to have difficulty in airway management (modified Marhalanobis score IV); Patients with severe respiratory tract pathologies (obstructive sleep apnea syndrome, mouth opening disorder, limited neck or jaw movement, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.); 8.Sitting systolic blood pressure < 90mmHg during the screening period; Females who are pregnant or lactating; 9.Those who are allergic to benzodiazepines, opioids, propofol and other drugs or their drug components; 10. Participated in drug clinical trials as a patient in the past 3 months; 11.Those who are considered by the investigator to be inappropriate to participate in this trial.

Design outcomes

Primary

Measure	Time frame
The extent of amnesia in patients with different doses remimazolam tosylate;	—

Secondary

Measure	Time frame
Effect of different doses of remimazolam on amnesia in patients of different age groups;Hemodynamic changes;The time of disappearance of consciousness and body movement after induction of general anesthesia in patients with different doses of remimazolam assisted sedation;	—

Countries

China

Contacts

Public ContactHao Cheng

The First Affiliated Hospital of Soochow University

chenghaojs@163.com+86 139 0621 7420

Outcome results

None listed

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