Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 15
- 主要终点
- Number of Participants With Body Movement During Anesthetic Maintenance
研究概览
简要总结
The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.
详细描述
The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA PS 1-3
- •age: older than 19 y and younger than 70 y
- •undergoing surgery of the thorax(thoracotomy, thoracotomy plus laparotomy, endoscopy; but excluding cardiovascular),abdomen(laparotomy,endoscopy;but excluding cesarean section), joints (including peripheral vessels), back (spine)or neck (neck, throat)
- •willing to be hospitalized for at least 3 days and 2 nights (from the day before surgery to the day after surgery)
- •having given written consent
排除标准
- •need for spinal subarachnoid, epidural or local anesthesia (except local surface or infiltration anesthesia for catheter insertion or use of local anesthetic for testing before inserting epidural catheter for post-surgical pain)
- •contraindication for use of nitrous during surgery
- •anticipated need for postoperative transfer to intensive care unit and receive mechanical pulmonary ventilation
- •BMI of 30 kg/m2 or more
- •serious hepatic, renal, or circulatory disorder (Grade 3 per Notification 80 by MHW, Pharmaceutical Affairs Bureau, Safety Division)
- •uncontrollable hypertension (SBP 160 mmHg or higher while on antihypertensive therapy)
- •emergency surgery
- •history of hypersensitivity to components of sevoflurane, fentanyl, propofol, vecuronium or other anesthetic
- •contraindication to sevoflurane, fentanyl, propofol, or vecuronium
- •exposure or suspected exposure to inhalational halogenated anesthetic within 3 mo prior to consent
- •known or suspected history or family history of malignant hyperthermia
- •considered likely to have difficulty in receiving tracheal intubation due to conditions such as brachygnathia, micrognathia, bucked teeth, articular rheumatism or injury of cervical spine/cervical cord
- •known or suspected to be pregnant or lactating
- •participated in a clinical study within 6 mo prior to consent
- •history of drug dependence
- •history of epilepsy
- •otherwise judged by the investigator to be unsuitable for the study
研究组 & 干预措施
desflurane
干预措施: desflurane (Drug)
desflurane/N2O
干预措施: desflurane/nitrous oxide (Drug)
sevoflurane/N2O
干预措施: sevoflurane/nitrous oxide (Drug)
结局指标
主要结局
Number of Participants With Body Movement During Anesthetic Maintenance
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.
Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Rescue medication includes vasopressors and depressors.
Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
"Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to \<150 mmHg and heart rate 50 to \<100 bpm could be maintained "
Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate
Overall Assessment of Efficacy
时间窗: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.
Time to Extubation
时间窗: Day 1 (Post-Surgery, from end of study drug inhalation to extubation)
Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation \>=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: \>=100 mmHg).
次要结局
- Time to Awakening(Day 1 (Post-Surgery, from the end of study drug inhalation to awakening))
- Time to Stating Birth Date(Day 1 (Post-Surgery, after extubation))
- Time to Reaching an Aldrete Score >=8 (Min)(Day 1 (Post-Surgery, after extubation))
- Time to Clear Consciousness(Day 1 (Post-Surgery, from awakening to before extubation))
- Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance(Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours))
- Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate(Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours))
- Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate(Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours))
- Number of Participants Requiring Rescue Medication Due to Arrhythmia(Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours))
- Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance(Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation])
- Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance(Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation])
- End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia(Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation])