Determining the effective dose of fospropofol for anesthesia in adults
90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
This study is testing the right amount of a new anesthesia drug called fospropofol to see how well it works for adults having elective surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06344325 on ClinicalTrials.gov |
What this trial studies
This study investigates the 90% effective dose (ED90) of fospropofol disodium for inducing and maintaining anesthesia in adults undergoing elective surgery. Fospropofol disodium is a water-soluble precursor to propofol, offering advantages such as a longer duration of action and reduced injection pain. The trial aims to gather clinical evidence on its effective dosage across different age groups, addressing a gap in current knowledge regarding its application in anesthesia. Participants will be monitored for efficacy and safety during the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 years scheduled for elective surgery requiring general anesthesia.
Not a fit: Patients with severe comorbidities or contraindications to fospropofol, such as ASA classification III or higher, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer anesthetic option for patients undergoing elective surgeries.
How similar studies have performed: While there is limited clinical observation on fospropofol disodium, the study aims to fill a knowledge gap, suggesting that this approach is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: mujun Chang, Dr.
- Email: changmujun@hotmail.com
- Phone: +862783663625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.