Opioid-Free Combined Anesthesia Under Spontaneous Breathing for Video-Assisted Thoracoscopic Surgery of Pulmonary Nodules: A Multicenter, Open-Label, Randomized Controlled, 2x2 Factorial Design Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Lung function 30 days after surgery
研究概览
简要总结
Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience.
详细描述
This study is a prospective, multicenter, randomized controlled, open-label, 2x2 factorial design trial involving two types of interventions: ventilation methods (2 levels: preserved spontaneous breathing, mechanical ventilation) and combined anesthesia methods (2 levels: opioid-free combined anesthesia, opioid-based combined anesthesia). To evaluate the clinical efficacy and safety of these two types of interventions, four parallel groups of patients undergoing video-assisted thoracoscopic surgery for pulmonary nodules under different anesthesia strategies were established: preserved spontaneous breathing and opioid-based combined anesthesia (OSB group), preserved spontaneous breathing and opioid-free combined anesthesia (KSB group), double-lumen endotracheal tube mechanical ventilation and opioid-based combined anesthesia (OMV group), and double-lumen endotracheal tube mechanical ventilation and opioid-free combined anesthesia (KMV group). This study will be conducted in the thoracic surgical centers of six hospitals in China, carried out by experienced senior anesthetists and thoracic surgeons. Patients undergoing anesthesia in this study will experience three observation phases. Phase 1 (perioperative phase, day 0 to day 2): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the perioperative period; Phase 2 (postoperative hospital stay, day 3 to day 7): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the hospital stay; Phase 3 (short-term follow-up, day 8 to day 30): Observing the lung function status and the occurrence of adverse events under different anesthesia plans during the short-term follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grades 1-2
- •Age > 18 years and < 70 years
- •Male or female patients
- •VATS pulmonary nodule operation is planned under general anesthesia
- •Voluntarily participate in the study and sign the informed consent
排除标准
- •Subject's operation is aborted
- •Serious adverse events, complications or special physiological changes during the perioperative period should not be continued
- •Expansion of surgical scope: resection of complex lung segment or complex lung lobectomy, thoracoscopic assisted small-incision surgery with enlarged incision, requiring pulmonary blood Tracheoplasty or bronchoplasty, partial pericardiectomy or conversion to thoracotomy
- •Those who need a second operation within a month
- •The patient or his/her guardian requests to withdraw on his/her own
- •Reasons why other researchers think the study needs to be discontinued
研究组 & 干预措施
OSB
Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.
干预措施: opioid based strategy (Drug)
OSB
Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.
干预措施: Laryngeal mask airway; Preserved spontaneous breathing (Procedure)
KSB
Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.
干预措施: opioid-free strategy (Drug)
KSB
Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.
干预措施: Laryngeal mask airway; Preserved spontaneous breathing (Procedure)
OMV
Anesthesia was induced by intravenous sufentanil injection of 0.5 μg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-lumen bronchial tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with initial intravenous pump of propofol (5 mg/kg/h) and remifentanil (0.1 μg/kg/min) first , and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.
干预措施: opioid based strategy (Drug)
OMV
Anesthesia was induced by intravenous sufentanil injection of 0.5 μg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-lumen bronchial tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with initial intravenous pump of propofol (5 mg/kg/h) and remifentanil (0.1 μg/kg/min) first , and then adjusted according to the depth of anesthesia.
Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.
干预措施: Double lumen tracheal tube; Mechanical ventilation (Procedure)
KMV
Anesthesia was induced by intravenous injection of esketamine 0.5 mg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-chamber tracheal tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with the initial intravenous pump of propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h) first , and then adjusted according to the depth of anesthesia. Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.
干预措施: opioid-free strategy (Drug)
KMV
Anesthesia was induced by intravenous injection of esketamine 0.5 mg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-chamber tracheal tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with the initial intravenous pump of propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h) first , and then adjusted according to the depth of anesthesia. Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.
干预措施: Double lumen tracheal tube; Mechanical ventilation (Procedure)
结局指标
主要结局
Lung function 30 days after surgery
时间窗: 30 days after surgery
FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.
次要结局
- The 6-minute walking experiment(30 days after surgery.)
- Intraoperative respiratory parameters(At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation)
- Postoperative Lung function(1, 3, 5 days after surgery)
- Perioperative stage indicators(At the end of the operation)
- Postoperative pain(Six hours, 24 hours, 48 hours after surgery)
- Postoperative depression/anxiety(Before surgery, 2 days after surgery)
- Postoperative pulmonary complications(1, 3, 5 days after surgery)
- Postoperative gastrointestinal function(Six hours, 24 hours, 48 hours after surgery)
- Postoperative cognitive function(Before surgery, 1 day after surgery, 3 days after surgery)
- Time of first exercise after surgery(From the end of surgery，Until the first time of off-bed activity)
- Length of stay(From date of surgery Until the date of discharge or death)
- Quality of life measurement(the date of discharge，and Thirty days after surgery)
- Intraoperative circulation parameters(At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation)