Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Incidence of injection pain
研究概览
简要总结
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.
详细描述
- To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
- Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Fospropofol group
patients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium.
干预措施: Fospropofol (Drug)
Propofol group
patients in the propofol group received propofol, sufentanil, and rocuronium.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of injection pain
时间窗: During induction of anesthesia
Incidence of perceived injection pain during anesthesia induction
Incidence of perioperative hypotension
时间窗: From the beginning to the end of surgery
Incidence of hypotension throughout perioperative period
次要结局
- Glomerular filtration rate(First day after surgery)
- Urea nitrogen(First day after surgery)
- Creatinine(First day after surgery)
- Eeg dual frequency exponential waveform(From the beginning to the end of surgery)
研究者
Hui Xu
Professor
Tongji Hospital