Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
- Conditions
- Drug Safety
- Registration Number
- NCT06573489
- Lead Sponsor
- Hui Xu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Adult age (18-65 years old)<br><br> 2. ASA(American Society of Anesthesiologists)grade I~II<br><br> 3. The estimated operation time is more than 3h, and laparoscopic abdominal surgery<br> under general anesthesia is planned<br><br> 4. BMI value 18-30kg /m2<br><br> 5. Voluntary signing of informed consent<br><br>Exclusion Criteria:<br><br> 1. Those who have contraindications to general anesthesia or have a history of<br> anesthesia accidents;<br><br> 2. Patients with craniocerebral loss, intracranial hypertension, stroke, unstable<br> angina pectoris, myocardial infarction;<br><br> 3. Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult<br> airway, or determination of tracheal intubation difficulty (modified Markov score<br> level III or IV)<br><br> 4. uncontrolled diabetes or high blood pressure;<br><br> 5. A history of drug use, alcoholism or drug dependence;<br><br> 6. Abuse or long-term use of narcotic, sedative and analgesic drugs;<br><br> 7. Those who are known or suspected to be allergic to or contraindicated by the process<br> administration of various components or protocols of the study drug (sufentanil<br> citrate injection, propofol medium/long chain fat milk, remifentanil hydrochloride<br> for injection, and propofol disodium for injection);<br><br> 8. People with a history of mental illness;<br><br> 9. Participants in any drug clinical trial within 1 month before screening;<br><br> 10. Pregnant and lactating women; The reluctance of fertile women or men to use<br> contraception throughout the trial; Subjects (including male subjects) who plan to<br> become pregnant within 3 months after the trial;<br><br> 11. Subjects who have any other factors deemed unsuitable by the investigator for<br> participation in this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of perioperative hypotension;Incidence of injection pain
- Secondary Outcome Measures
Name Time Method Glomerular filtration rate;Eeg dual frequency exponential waveform;Urea nitrogen;Creatinine