Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-07
Brief Title:
Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nauseavomiting cognitive function and depressionanxiety 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None