Tongji Hospital
Wuhan, Hubei, China
Location status: Recruiting
NCT Number: NCT06367218
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 30 days after surgery
FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.
Time frame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
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
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
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
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
dynamic lung compliance
Time frame: At the end of the operation
Blood loss, intraoperative transfusion
Time frame: At the end of the operation
operation time, anesthesia time, recovery time
Time frame: Six hours, 24 hours, 48 hours after surgery
Postoperative pain (numerical rating scale (NRS))
Time frame: 1, 3, 5 days after surgery
FVC, FEV1, FEV1 (% pred)
Time frame: 1, 3, 5 days after surgery
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
european perioperative clinical outcome (EPCO)
Time frame: Six hours, 24 hours, 48 hours after surgery
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: Before surgery, 2 days after surgery
(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, 1 day after surgery, 3 days after surgery
(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: From the end of surgery,Until the first time of off-bed activity
objective parameters included stable vital signs, no obvious bleeding tendency, NRS score less than 5 points
Time frame: 30 days after surgery.
Measure the distance covered by an individual walking for 6 minutes at the highest speed
Time frame: From date of surgery Until the date of discharge or death
The number of days spent in the hospital from the end of surgery until discharge or death
Time frame: the date of discharge,and Thirty days after surgery
Use a WHOQOL-BREF scale rating to evaluate quality of life
Time frame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
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
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
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
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
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
urine volume
Contact information is provided by the study sponsor or research team.
Tongji Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.