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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fospropofol

    Drug

    Use fospropofol for general anesthesia maintenance

  • Propofol

    Drug

    Use propofol for general anesthesia maintenance

Treatment groups

373 Participants
are divided into 2 treatment groups
Group A: Fospropofol groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of perioperative hypotension

Incidence of hypotension throughout perioperative period

Time frame
From the beginning to the end of surgery
2

Incidence of injection pain

Incidence of perceived injection pain during anesthesia induction

Time frame
During induction of anesthesia

Secondary outcomes

1

Glomerular filtration rate

The patients' glomerular filtration rate

Time frame
First day after surgery
2

Eeg dual frequency exponential waveform

Eeg dual frequency index waveform during operation

Time frame
From the beginning to the end of surgery
3

Urea nitrogen

Blood level of urea nitrogen

Time frame
First day after surgery
4

Creatinine

Blood level of creatinine

Time frame
First day after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hui Xu

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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