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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
480
Induction and maintenance of anesthesia with opioids
Esketamine was used for induction and maintenance of anesthesia
The patient used a laryngeal mask to maintain spontaneous breathing
The patient was mechanically ventilated using a double-lumen tracheal catheter
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGLung function 30 days after surgery
FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.
Time frame: 30 days after surgery
Intraoperative respiratory parameters
Airway peak pressure
Time frame: 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
oxygenation index (OI=PaO2/FiO2)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: At the end of the operation
Perioperative stage indicators
operation time, anesthesia time, recovery time
Time frame: At the end of the operation
Postoperative pain
Postoperative pain (numerical rating scale (NRS))
Time frame: Six hours, 24 hours, 48 hours after surgery
Postoperative Lung function
FVC, FEV1, FEV1 (% pred)
Time frame: 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.
Time frame: 1, 3, 5 days after surgery
Postoperative pulmonary complications
european perioperative clinical outcome (EPCO)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 30 days after surgery.
Length of stay
The number of days spent in the hospital from the end of surgery until discharge or death
Time frame: 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
Time frame: the date of discharge，and Thirty days after surgery
Intraoperative circulation parameters
Blood pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
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