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

ConditionDrug Safety
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHui Xu

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Fospropofol
  • Propofol

Treatment groups

373 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hui Xu

Lead sponsor

Tongji Hospital

Sponsor institution