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

NCT06573489 | Recruiting Phase 4

• 1 other identifier: TJ-IRB202405048
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Safety

Keywords

Fospropofol; Efficacy and Safety

Outcome Measures

Primary Outcomes (2)

• Incidence of perioperative hypotension

  Incidence of hypotension throughout perioperative period

  From the beginning to the end of surgery

• Incidence of injection pain

  Incidence of perceived injection pain during anesthesia induction

  During induction of anesthesia

Secondary Outcomes (4)

• Glomerular filtration rate

  First day after surgery

• Eeg dual frequency exponential waveform

  From the beginning to the end of surgery

• Urea nitrogen

  First day after surgery

• Creatinine

  First day after surgery

Study Arms (2)

Fospropofol group

EXPERIMENTAL

patients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium.

Drug: Fospropofol

Propofol group

ACTIVE COMPARATOR

patients in the propofol group received propofol, sufentanil, and rocuronium.

Drug: Propofol

Interventions

Fospropofol DRUG

Use fospropofol for general anesthesia maintenance

Also known as: fospropofol disodium

Fospropofol group

Propofol DRUG

Use propofol for general anesthesia maintenance

Also known as: Diprivan propofol

Propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hui Xu: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Related Publications (2)

• Dinis-Oliveira RJ. Metabolic Profiles of Propofol and Fospropofol: Clinical and Forensic Interpretative Aspects. Biomed Res Int. 2018 May 24;2018:6852857. doi: 10.1155/2018/6852857. eCollection 2018.

  PMID: 29992157 BACKGROUND

• Patwardhan A, Edelmayer R, Annabi E, Price T, Malan P, Dussor G. Receptor specificity defines algogenic properties of propofol and fospropofol. Anesth Analg. 2012 Oct;115(4):837-40. doi: 10.1213/ANE.0b013e318258b9db. Epub 2012 May 14.

  PMID: 22584560 RESULT

MeSH Terms

Interventions

fospropofol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tao Hong, Master

  Tongji Hospital, Tongji Medical College, Huazhong University of Scien

  STUDY DIRECTOR

Central Study Contacts

Tao Hong, Master

CONTACT

15927008056; whutthong@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 27, 2024
• Study Start: September 15, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)