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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Fospropofol
  Use fospropofol for general anesthesia maintenance
• Препарат Propofol
  Use propofol for general anesthesia maintenance

Первичные конечные точки

• Incidence of perioperative hypotension [Срок оценки: From the beginning to the end of surgery]
• Incidence of injection pain [Срок оценки: During induction of anesthesia]

Вторичные конечные точки (4)

• Glomerular filtration rate [Срок оценки: First day after surgery]
• Eeg dual frequency exponential waveform [Срок оценки: From the beginning to the end of surgery]
• Urea nitrogen [Срок оценки: First day after surgery]
• Creatinine [Срок оценки: First day after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital — Ухань

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06573489 · TJ-IRB202405048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗