A Randomized, Multi-center, Parallel group, Active comparator, Single blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HNP-2001in Surgical Patients undergoing General Anesthesia
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 198
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the safety of HNP-2001 (study drug) vs. Propofol (control) for the induction and the maintenance of general anesthesia in patients undergoing elective surgery with general anesthesia. In the primary efficacy evaluation, the success rate of general anesthesia was similar in the HNP-2001group and the comparator group.There was no statistically significant difference in the incidence of localized adverse events and of excluded localized adverse events in the HNP-2001 and comparator groups. Also, there was no serious adverse event occurred. These results confirm the efficacy and safety of the HNP-2001 for the induction and maintenance of general anesthesia in surgical patients, and it is expected to act as an anesthetic drugs that does not cause circulatory system problems.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Male or female = 18 years of age at the day of consent
- •2)Patients scheduled for surgery requiring ventilator with endotracheal intubation
- •3)American Society of Anesthesiologists (ASA) Physical status ? or ?
- •4)Patients who voluntarily choose to participate in the study and sign a written informed consent form
排除标准
- •1)Patients scheduled to have local anesthesia (spinal subarachnoid anesthesia, epidural anesthesia, peripheral nerve block) between Day 1 operating room entrance and the end of endotracheal intubation
- •2)Planned to have hepatic resection or liver transplantation during the surgery
- •3)Planned to use heart-lung machine during the surgery (e.g., cardiotomy, heart transplantation, lung transplantation, etc.)
- •4)Uncontrolled hypertension (SBP = 180 mmHg [= 160 mmHg for patients taking anti-hypertensives] at screening)
- •5)Uncontrolled diabetes mellitus (HbA1c = 9% at screening)
- •6)Patients with chronic obstructive pulmonary disease requiring treatment or patients who require the maintenance of endotracheal intubation for post-operative respiration management expected to result in difficulty in immediate removal of intubation
- •7)Resistance to benzodiazepines
- •8)Hypersensitivity to benzodiazepines, propofol, remifentanil, fentanil citrate, rocuronium bromide, sugammadex, flumazenil, and other anesthetics
- •9)Investigator otherwise judges that the patient is not eligible for the study participation