RecruitingNot ApplicableNCT06367218

Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS

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


Sponsor

Tongji Hospital

Enrollment

480 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DRUGopioid based strategy

Induction and maintenance of anesthesia with opioids

DRUGopioid-free strategy

Esketamine was used for induction and maintenance of anesthesia

PROCEDURELaryngeal mask airway; Preserved spontaneous breathing

The patient used a laryngeal mask to maintain spontaneous breathing

PROCEDUREDouble lumen tracheal tube; Mechanical ventilation

The patient was mechanically ventilated using a double-lumen tracheal catheter


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT06367218