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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSB | Experimental | 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. |
|
| KSB | Experimental | 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. |
|
| OMV | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioid based strategy | Drug | Induction and maintenance of anesthesia with opioids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function 30 days after surgery | FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative respiratory parameters | Airway peak pressure | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative respiratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Xu, Professor | Contact | (86)-13971001596 | huixu@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| KMV | Experimental | 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. |
|
| opioid-free strategy |
| Drug |
Esketamine was used for induction and maintenance of anesthesia |
|
| Laryngeal mask airway; Preserved spontaneous breathing | Procedure | The patient used a laryngeal mask to maintain spontaneous breathing |
|
| Double lumen tracheal tube; Mechanical ventilation | Procedure | The patient was mechanically ventilated using a double-lumen tracheal catheter |
|
oxygenation index (OI=PaO2/FiO2)
| At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative respiratory parameters | alveolar arterial oxygen partial pressure difference (P(A-a)DO2) | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative respiratory parameters | respiratory index (RI=P(A-a)DO2 /PaO2) | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative respiratory parameters | dynamic lung compliance | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Perioperative stage indicators | Blood loss, intraoperative transfusion | At the end of the operation |
| Perioperative stage indicators | operation time, anesthesia time, recovery time | At the end of the operation |
| Postoperative pain | Postoperative pain (numerical rating scale (NRS)) | Six hours, 24 hours, 48 hours after surgery |
| Postoperative Lung function | FVC, FEV1, FEV1 (% pred) | 1, 3, 5 days after surgery |
| Postoperative Lung function | Copd Patient Self-Assessment Test (CAT)，Scores range from 0 to 40, with ≥10 indicating the need for medical intervention. | 1, 3, 5 days after surgery |
| Postoperative pulmonary complications | european perioperative clinical outcome (EPCO) | 1, 3, 5 days after surgery |
| Postoperative gastrointestinal function | Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system, I-FEED，0 ~ 2 points, normal; 3 ~ 5 scores, postoperative gastrointestinal functional intolerance; ≥6 points, POGD. | Six hours, 24 hours, 48 hours after surgery |
| Postoperative depression/anxiety | (hospital anxiety and depression scale, HADS) scale score，Anxiety and depression were divided into two subscales: 0-7 was negative; 8-10 is mild; 11-14 divided into moderate; 15 to 21 is classified as severe | Before surgery, 2 days after surgery |
| Postoperative cognitive function | (mini-mental state examination, MMSE) scale score，The maximum score is 30 points. The classification of dementia is related to the level of education, so if the elderly are illiterate and less than 17 points, primary school and less than 20 points, secondary school and above less than 24 points, then dementia. | Before surgery, 1 day after surgery, 3 days after surgery |
| Time of first exercise after surgery | objective parameters included stable vital signs, no obvious bleeding tendency, NRS score less than 5 points | From the end of surgery，Until the first time of off-bed activity |
| The 6-minute walking experiment | Measure the distance covered by an individual walking for 6 minutes at the highest speed | 30 days after surgery. |
| Length of stay | The number of days spent in the hospital from the end of surgery until discharge or death | From date of surgery Until the date of discharge or death |
| Quality of life measurement | Use a WHOQOL-BREF scale rating to evaluate quality of life | the date of discharge，and Thirty days after surgery |
| Intraoperative circulation parameters | Blood pressure | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative circulation parameters | heart rate | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative circulation parameters | pulse oxygen saturation | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative circulation parameters | anesthesia depth index | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative circulation parameters | body temperature | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| Intraoperative circulation parameters | urine volume | At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D012138 | Respiratory Therapy |