Elective Surgery
Conditions
Brief summary
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
Detailed description
As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.
Interventions
DRUGfospropofol
The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.
Sponsors
Tongji Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation score | 1 day | Sedation score (MOAA/S) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative adverse reactions | 1 day | Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness. |
Countries
China
Outcome results
None listed