Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial (NCT06573489) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
China373 participantsStarted 2024-09-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
✕. 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;
✕
What they're measuring
1
Incidence of perioperative hypotension
Timeframe: From the beginning to the end of surgery
. 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);