Clinical trial NCT06367218: Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ASA grades 1-2
2. Age \> 18 years and \< 70 years
3. Male or female patients
4. VATS pulmonary nodule operation is planned under general anesthesia
5. Voluntarily participate in the study and sign the informed consent

Exclusion Criteria:

1. Subject's operation is aborted
2. Serious adverse events, complications or special physiological changes during the perioperative period should not be continued
3. 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
4. Those who need a second operation within a month
5. The patient or his/her guardian requests to withdraw on his/her own
6. Reasons why other researchers think the study needs to be discontinued

Primary outcomes:
measure: Lung function 30 days after surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Intraoperative respiratory parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative respiratory parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative respiratory parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative respiratory parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative respiratory parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Perioperative stage indicators
timeFrame: At the end of the operation
measure: Perioperative stage indicators
timeFrame: At the end of the operation
measure: Postoperative pain
timeFrame: Six hours, 24 hours, 48 hours after surgery
measure: Postoperative Lung function
timeFrame: 1, 3, 5 days after surgery
measure: Postoperative Lung function
timeFrame: 1, 3, 5 days after surgery
measure: Postoperative pulmonary complications
timeFrame: 1, 3, 5 days after surgery
measure: Postoperative gastrointestinal function
timeFrame: Six hours, 24 hours, 48 hours after surgery
measure: Postoperative depression/anxiety
timeFrame: Before surgery, 2 days after surgery
measure: Postoperative cognitive function
timeFrame: Before surgery, 1 day after surgery, 3 days after surgery
measure: Time of first exercise after surgery
timeFrame: From the end of surgery，Until the first time of off-bed activity
measure: The 6-minute walking experiment
timeFrame: 30 days after surgery.
measure: Length of stay
timeFrame: From date of surgery Until the date of discharge or death
measure: Quality of life measurement
timeFrame: the date of discharge，and Thirty days after surgery
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
measure: Intraoperative circulation parameters
timeFrame: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: