Elective Surgery Clinical Trial
Official title:
90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia
Status | Not yet recruiting |
Enrollment | 330 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Aged 18-80 years old, elective surgery under general anesthesia. - ASA I-II; - Surgical duration>30 minutes; - Sign an informed consent form. Exclusion Criteria: - American Society of Anesthesiologists(ASA)= III; - Body mass index (BMI)<18 kg/m2 or>30 kg/m2; - Individuals with a history or potential history of drug abuse or alcohol dependence; - Preoperative use of sedative or analgesic drugs; - Individuals with severe liver and kidney dysfunction; - Individuals who are allergic or potentially allergic to propofol and lipids; - The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures; - Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status; - Participants in other clinical studies within the past 3 months; - researchers deemed it inappropriate for participants to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | Tongji hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sedation score | Sedation score (MOAA/S) | 1 day | |
Secondary | Postoperative adverse reactions | Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness. | 1 day |
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