ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Launched by TONGJI HOSPITAL · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fospropofol disodium, which is used to help put patients to sleep and keep them comfortable during elective surgeries. The researchers are trying to determine the dose of this medication that is effective for 90% of people undergoing surgery. This study aims to gather more information about how fospropofol can be safely used in different age groups during anesthesia.

To participate in this trial, you need to be between 18 and 80 years old and scheduled for a surgery that lasts longer than 30 minutes. You should be in good health (classified as ASA I-II) and able to provide informed consent. However, if you have certain health issues, like severe liver or kidney problems, or a history of substance abuse, you may not be eligible. If you join, you can expect careful monitoring during your procedure and support from the medical team to ensure your safety and comfort. This research will help improve anesthesia practices and make surgeries safer for everyone.

Gender

ALL

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.