Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study
Hui Xu
373 participants
Sep 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Adult age (18-65 years old)
- ASA（American Society of Anesthesiologists）grade I~II
- The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned
- BMI value 18-30kg /m2
- Voluntary signing of informed consent
Exclusion Criteria11
- Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
- Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;
- Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)
- uncontrolled diabetes or high blood pressure;
- A history of drug use, alcoholism or drug dependence;
- Abuse or long-term use of narcotic, sedative and analgesic drugs;
- 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);
- People with a history of mental illness;
- Participants in any drug clinical trial within 1 month before screening;
- 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;
- Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.
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Interventions
Use fospropofol for general anesthesia maintenance
Use propofol for general anesthesia maintenance
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06573489