Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: opioid based strategy, opioid-free strategy, Laryngeal mask airway; Preserved spontaneous breathing, Double lumen tracheal tube; Mechanical ventilation.
- Who it may be relevant to
- Registry conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug opioid based strategy
Induction and maintenance of anesthesia with opioids - Drug opioid-free strategy
Esketamine was used for induction and maintenance of anesthesia - Procedure Laryngeal mask airway; Preserved spontaneous breathing
The patient used a laryngeal mask to maintain spontaneous breathing - Procedure Double lumen tracheal tube; Mechanical ventilation
The patient was mechanically ventilated using a double-lumen tracheal catheter
Primary outcome measures
- Lung function 30 days after surgery [Time frame: 30 days after surgery]
Secondary outcome measures (12)
- Intraoperative respiratory parameters [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 [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 [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 [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 [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 [Time frame: At the end of the operation]
- Perioperative stage indicators [Time frame: At the end of the operation]
- Postoperative pain [Time frame: Six hours, 24 hours, 48 hours after surgery]
- Postoperative Lung function [Time frame: 1, 3, 5 days after surgery]
- Postoperative Lung function [Time frame: 1, 3, 5 days after surgery]
- Postoperative pulmonary complications [Time frame: 1, 3, 5 days after surgery]
- Postoperative gastrointestinal function [Time frame: Six hours, 24 hours, 48 hours after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Subject's operation is aborted
- Serious adverse events, complications or special physiological changes during the perioperative period should not be continued
- 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
- Those who need a second operation within a month
- The patient or his/her guardian requests to withdraw on his/her own
- Reasons why other researchers think the study needs to be discontinued
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Tongji Hospital — Wuhan
Identifiers
NCT: NCT06367218 · S036