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
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Hui Xu, Professor
huixu@tjh.tjmu.edu.cn
(86)-13971001596
Time Frame
Start Date:2024-10-01
Estimated Completion Date:2026-08-01
Participants
Target number of participants:480
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.