Using fospropofol for anesthesia in adult laparoscopic surgery

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

This study is testing if a new anesthesia drug called fospropofol is safe and effective for adults having laparoscopic abdominal surgery, compared to the traditional drug propofol.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 373 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06573489 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of fospropofol disodium as a general anesthesia agent in adults undergoing laparoscopic abdominal surgery. The study aims to determine the lowest effective dose for anesthesia induction and evaluate its efficacy and safety during the maintenance phase. Additionally, it will monitor changes in the Bispectral Index (BIS) during different phases of anesthesia to compare fospropofol with traditional propofol. The trial is designed as a randomized, single-blind, controlled study with an expected enrollment of 373 patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with ASA grade I-II who are scheduled for laparoscopic abdominal surgery lasting more than three hours.

Not a fit: Patients with contraindications to general anesthesia, significant comorbidities, or a history of anesthesia complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved anesthesia protocols that enhance patient safety and recovery during laparoscopic surgeries.

How similar studies have performed: While the use of fospropofol is established, this specific application in laparoscopic surgery is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Tao Hong, Master

Conditions Drug Safety; Fospropofol; Efficacy and Safety