Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial

Launched by HUI XU · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fospropofol disodium, which is used for general anesthesia during laparoscopic (minimally invasive) abdominal surgery in adults. The main goals of the study are to find out the lowest effective dose of fospropofol for starting anesthesia, to evaluate how safe and effective it is during the surgery, and to understand how it affects patients as they go through different stages of anesthesia. The researchers will compare fospropofol to another medication called propofol to see how they differ in their effects.

To participate in this trial, you need to be an adult between the ages of 18 and 65, be healthy enough for surgery, and have a scheduled laparoscopic procedure that is expected to take more than three hours. However, there are some important reasons why someone might not be eligible, such as having serious health issues like heart problems, difficulty breathing, or a history of complications with anesthesia. If you join the study, you'll be one of about 373 people who will receive either fospropofol or propofol during your surgery, and your experience will help researchers learn more about this medication's safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult age (18-65 years old)
• • 2. ASA（American Society of Anesthesiologists）grade I\~II
• • 3. The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned
• • 4. BMI value 18-30kg /m2
• • 5. Voluntary signing of informed consent
• Exclusion Criteria:
• • 1. Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
• • 2. Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;
• • 3. Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)
• • 4. uncontrolled diabetes or high blood pressure;
• • 5. A history of drug use, alcoholism or drug dependence;
• • 6. Abuse or long-term use of narcotic, sedative and analgesic drugs;
• • 7. Those who are known or suspected to be allergic to or contraindicated by the process administration of various components or protocols of the study drug (sufentanil citrate injection, propofol medium/long chain fat milk, remifentanil hydrochloride for injection, and propofol disodium for injection);
• • 8. People with a history of mental illness;
• • 9. Participants in any drug clinical trial within 1 month before screening;
• • 10. Pregnant and lactating women; The reluctance of fertile women or men to use contraception throughout the trial; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
• • 11. Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.