Drug Safety
Conditions
Keywords
Fospropofol, Efficacy and Safety
Brief summary
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.
Detailed description
1. To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery 2. Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery 3. To study the changes of Bispectral Index in the brain of patients treated with propofol during induction, maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults, and to compare with BIS（Bispectral Index） monitoring under propofol, and to study the characteristic changes of BIS（Bispectral Index） waveform in patients treated with propofol disodium.
Interventions
DRUGFospropofol
Use fospropofol for general anesthesia maintenance
DRUGPropofol
Use propofol for general anesthesia maintenance
Sponsors
Hui Xu
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perioperative hypotension | From the beginning to the end of surgery | Incidence of hypotension throughout perioperative period |
| Incidence of injection pain | During induction of anesthesia | Incidence of perceived injection pain during anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular filtration rate | First day after surgery | The patients' glomerular filtration rate |
| Eeg dual frequency exponential waveform | From the beginning to the end of surgery | Eeg dual frequency index waveform during operation |
| Urea nitrogen | First day after surgery | Blood level of urea nitrogen |
| Creatinine | First day after surgery | Blood level of creatinine |
Countries
China
Contacts
Primary ContactTao Hong, Master
Outcome results
None listed