None listed
Conditions
Interventions
Group Remimazolam:Remimazolam besylate (concentration: 1 mg·ml-1) was administered via intravenous infusion pump at a rate of 12 mg·kg-1·h?1 for sedation. Upon loss of consciousness (LoC, defined as l
Group Propofol:Propofol injection (concentration: 10 mg·ml-1) was administered via intravenous infusion pump at a rate of 1,200 ml·h-1 for sedation. Upon loss of consciousness (LoC), the infusion rate
Sponsors
Min Dong Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Patients scheduled for elective gynecological laparoscopic surgery requiring tracheal intubation; (2) Patients with a primary diagnosis of uterine fibroids or adenomyosis; (3) Surgical duration ranging from 90 to 150 minutes; (4) Aged 18 to 60 years; (5) American Society of Anesthesiologists (ASA) physical status classification I–III; (6) Body mass index (BMI) of 18.5–30 kg/m²; (7) Ability to comprehend the procedures and objectives of this study, and voluntary participation with informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects explicitly declined to participate in this study; (2) Individuals with contraindications for general anesthesia or a history of adverse anesthesia events; (3) Subjects with known or suspected hypersensitivity or contraindications to benzodiazepines, remimazolam besylate, propofol injection, flumazenil, opioids, neuromuscular blocking agents, etc.; (4) Patients with a history of severe hypersensitivity reactions to dextran 40 or products containing dextran 40; (5) Patients diagnosed with myasthenia gravis; (6) Individuals with schizophrenia or severe depressive disorders; (7) Subjects suspected of abusing narcotic analgesics or sedatives, or with a history of alcohol abuse; (8) Patients with a history of epilepsy or presenting with status epilepticus during the screening phase; (9) Subjects with severe cardiovascular, cerebral, pulmonary, hepatic, renal, or metabolic disorders; (10) Uncontrolled diabetes, preoperative systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg, or preoperative systolic blood pressure 100 beats/min, or severe arrhythmia; (12) Pregnant or lactating women; (13) Subjects deemed by the investigator to have any other factors rendering them unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time interval between discontinuation of maintenance anesthetic agents and tracheal extubation. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The QOR-15 score on the day before the operation;The QOR-15 score 24 hours after the operation;Time from anesthesia induction to loss of consciousness (LOC);Duration of PACU stay;MOAA/S score;Incidence of intraoperative awareness/recall; | — |
Countries
China
Contacts
Public ContactWENG DIGUI
Min Dong Hospital Affiliated to Fujian Medical University
Outcome results
None listed