Using fospropofol for anesthesia in adult laparoscopic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Tao Hong, Master
• Email: whutthong@126.com
• Phone: 15927008056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.