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NCT Number: NCT06573489

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

  • To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
  • Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Fospropofol

Drug

Use fospropofol for general anesthesia maintenance

Other names: fospropofol disodium

Propofol

Drug

Use propofol for general anesthesia maintenance

Other names: Diprivan propofol

Primary outcomes

  1. Incidence of perioperative hypotension

    Time frame: From the beginning to the end of surgery

    Incidence of hypotension throughout perioperative period

  2. Incidence of injection pain

    Time frame: During induction of anesthesia

    Incidence of perceived injection pain during anesthesia induction

Secondary outcomes

  1. Glomerular filtration rate

    Time frame: First day after surgery

    The patients' glomerular filtration rate

  2. Eeg dual frequency exponential waveform

    Time frame: From the beginning to the end of surgery

    Eeg dual frequency index waveform during operation

  3. Urea nitrogen

    Time frame: First day after surgery

    Blood level of urea nitrogen

  4. Creatinine

    Time frame: First day after surgery

    Blood level of creatinine

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Hong, Master

CONTACT

[email protected]

15927008056

Sponsors and collaborators

Lead sponsor

Hui Xu

Other

Registry information

Official study title

Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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