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

April 13, 2025 updated by: Hui Xu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
  2. Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
  3. 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.

Study Type

Interventional

Enrollment (Estimated)

373

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult age (18-65 years old)
  2. ASA（American Society of Anesthesiologists）grade I~II
  3. The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned
  4. BMI value 18-30kg /m2
  5. Voluntary signing of informed consent

Exclusion Criteria:

  1. Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
  2. Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;
  3. Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)
  4. uncontrolled diabetes or high blood pressure;
  5. A history of drug use, alcoholism or drug dependence;
  6. Abuse or long-term use of narcotic, sedative and analgesic drugs;
  7. 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);
  8. People with a history of mental illness;
  9. Participants in any drug clinical trial within 1 month before screening;
  10. 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;
  11. Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fospropofol group
patients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium.
Drug: Fospropofol
Use fospropofol for general anesthesia maintenance
Other Names:
  • fospropofol disodium
Active Comparator: Propofol group
patients in the propofol group received propofol, sufentanil, and rocuronium.
Drug: Propofol
Use propofol for general anesthesia maintenance
Other Names:
  • Diprivan propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of perioperative hypotension
Time Frame: From the beginning to the end of surgery
Incidence of hypotension throughout perioperative period
From the beginning to the end of surgery
Incidence of injection pain
Time Frame: During induction of anesthesia
Incidence of perceived injection pain during anesthesia induction
During induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate
Time Frame: First day after surgery
The patients' glomerular filtration rate
First day after surgery
Eeg dual frequency exponential waveform
Time Frame: From the beginning to the end of surgery
Eeg dual frequency index waveform during operation
From the beginning to the end of surgery
Urea nitrogen
Time Frame: First day after surgery
Blood level of urea nitrogen
First day after surgery
Creatinine
Time Frame: First day after surgery
Blood level of creatinine
First day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Xu

Investigators

  • Study Director: Tao Hong, Master, Tongji Hospital, Tongji Medical College, Huazhong University of Scien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202405048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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