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

NCT ID: NCT06573489

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2026-07-01

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.

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.

Conditions

Drug Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fospropofol group

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

Group Type: EXPERIMENTAL

Fospropofol

Intervention Type: DRUG

Use fospropofol for general anesthesia maintenance

Propofol group

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Use propofol for general anesthesia maintenance

Interventions

Fospropofol

Use fospropofol for general anesthesia maintenance

Intervention Type: DRUG

Propofol

Use propofol for general anesthesia maintenance

Intervention Type: DRUG

Other Intervention Names

fospropofol disodium; Diprivan propofol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui Xu

OTHER

Sponsor Role: lead

Responsible Party

Hui Xu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tao Hong, Master

Role: STUDY_DIRECTOR

Tongji Hospital, Tongji Medical College, Huazhong University of Scien

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Hong, Master

Role: CONTACT

whutthong@126.com

15927008056

Facility Contacts

Hui Xu

Role: primary

huixu@tjh.tjmu.edu.cn

+8613971001596

References

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.

Reference Type: BACKGROUND

PMID: 29992157 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22584560 (View on PubMed)

Other Identifiers

TJ-IRB202405048

Identifier Type: -

Identifier Source: org_study_id