Status:
RECRUITING
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
Lead Sponsor:
Hui Xu
Conditions:
Drug Safety
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT06573489
Start Date
September 15 2024
End Date
July 1 2026
Last Update
April 16 2025
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China