Not disease-specific
Conditions
Interventions
Experimental Group:Fospropofol Disodium for Injection
Sponsors
Qingbaijiang District People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years, any gender, BMI=18-30 kg/m²; (2) ASA physical status I or II; (3) Patients scheduled for elective surgery under general anesthesia; (4) Vital signs: Respiratory rate >=10 and =95% on room air; SBP >=90mmHg and =60mmHg and =55 and <=100 bpm; (5) Able to understand the study and voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Contraindications to general anesthesia or history of anesthesia accidents; (2) Known/suspected allergy or contraindication to propofol, fospropofol disodium, opioids, or muscle relaxants; (3) Comorbid traumatic brain injury, intracranial hypertension, stroke, unstable angina, or myocardial infarction; (4) Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or Mallampati class III/IV; (5) Severe hepatic/renal dysfunction; (6) Substance abuse or chronic use of anesthetics/sedatives/analgesics; (7) History of psychiatric disorders; (8) Participation in other drug trials within 1 month; (9) Pregnancy/lactation; Unwillingness to use contraception (fertile participants); Pregnancy plans within 1 month post-trial; (10) Other safety concerns per investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypotension during anesthesia induction (SBP =90mmHg); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to successful anesthesia induction: From initiation of study drug administration to MOAA/S score =1;Time to endotracheal intubation: From initiation of study drug administration to completed intubation; | — |
Countries
China
Contacts
Public ContactHua Ling
Chengdu Second People's Hospital
Outcome results
None listed