The Effect of Opioid-free Anesthesia on Postoperative Analgesia-related Adverse Reactions in Lung Resection With Video-assisted Thoracoscopic Access: a Randomized Double-blind Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
研究概览
简要总结
A comparison of incidences of postoperative opioid-related adverse effects and recovery parameters in patients undergoing video-assisted thoracoscopic surgery (VATS) lung resection receiving opioid or opioid-free general anesthesia (OFA).
详细描述
Video-assisted thoracoscopic surgery (VATS) lung resection is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of respiratory depression, hypotension, postoperative nausea and vomiting (PONV), dizziness, constipation and urinary retention, and more severe acute postoperative pain.
The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the primary outcome measures of the total incidence of opioid-related adverse effects (including respiratory depression, hypotension, PONV and dizziness) and secondary outcome measures of incidence of intraoperative and postoperative cardiovascular complications, pain relief, analgesic requirement , and other postoperative recovery parameters [e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively].
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing VATS lung resection.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Agreed to participate in the trial.
排除标准
- •Pregnant women
- •ASA phase III or above.
- •Undergoing emergency surgery.
- •Planning for thoracotomy.
- •Adults protected by law (under judicial protection, guardianship or supervision), people who deprived of their liberty.
- •Patients who have received general anesthesia.
- •Atrioventricular block, sinus node block or intraventricular block.
- •Sinus bradycardia (heart rate is less than 60 beats/min).
- •Preoperative hypotension (systolic blood pressure is less than 90mmHg)
- •Combined with urolithiasis, Meniere syndrome, and vertebral artery stenosis
- •Combined with cerebrovascular disease.
- •Contraindication to NSAIDs drug.
- •Allergic to anesthetics.
研究组 & 干预措施
opioid-free general anesthesia
under opioid-free general anesthesia
干预措施: Paravertebral block+Anterior serratus plane block (Procedure)
opioid-free general anesthesia
under opioid-free general anesthesia
干预措施: opioid free anesthesia (Drug)
opioid based general anesthesia
under opioid based general anesthesia
干预措施: Paravertebral block+Anterior serratus plane block (Procedure)
opioid based general anesthesia
under opioid based general anesthesia
干预措施: opioid based anesthesia (Drug)
结局指标
主要结局
Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
时间窗: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
The total incidence refers to the sum of the incidence of opioid-related adverse effects at 2h, 4h, 6h, 24h and 48h postoperationOpioid-related adverse effects here including respiratory depression, hypotension, PONV and dizziness.
次要结局
- Incidence of intraoperative cardiovascular complications(During the operation)
- Incidence of postoperative cardiovascular complications(Up to 30 days postoperation)
- Duration of tracheal intubation removing(Up to 2 hours postoperation)
- Duration of departing from PACU(Up to 4 hours postoperation)
- Pain severity(2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation)
- Dosage of opioids(2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation)
- Flatus time(Up to 48 hours postoperation)
- Defecation time(Up to 48 hours postoperation)
- Postoperative duration of stay in hospital(30 days postoperation)
研究者
Yi Feng, MD
Chief of the Anesthesiology Department
Peking University People's Hospital