90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
Overview
- Phase
- Phase 4
- Intervention
- fospropofol
- Conditions
- Elective Surgery
- Sponsor
- Tongji Hospital
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Sedation score
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
aijun xu
Clinical Professor
Tongji Hospital
Eligibility Criteria
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.
Arms & Interventions
Youth group
Youth group (18-45 years old)
Intervention: fospropofol
middle-aged group
middle-aged group (46-65 years old)
Intervention: fospropofol
elderly group
elderly group (66-80 years old)
Intervention: fospropofol
Outcomes
Primary Outcomes
Sedation score
Time Frame: 1 day
Sedation score (MOAA/S)
Secondary Outcomes
- Postoperative adverse reactions(1 day)