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NCT Number: NCT06367218

Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid based strategy

Drug

Induction and maintenance of anesthesia with opioids

opioid-free strategy

Drug

Esketamine was used for induction and maintenance of anesthesia

Laryngeal mask airway; Preserved spontaneous breathing

Procedure

The patient used a laryngeal mask to maintain spontaneous breathing

Double lumen tracheal tube; Mechanical ventilation

Procedure

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

Primary outcomes

  1. Lung function 30 days after surgery

    Time frame: 30 days after surgery

    FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.

Secondary outcomes

  1. 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

    Airway peak pressure

  2. 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

    oxygenation index (OI=PaO2/FiO2)

  3. 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

    alveolar arterial oxygen partial pressure difference (P(A-a)DO2)

  4. 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

    respiratory index (RI=P(A-a)DO2 /PaO2)

  5. 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

    dynamic lung compliance

  6. Perioperative stage indicators

    Time frame: At the end of the operation

    Blood loss, intraoperative transfusion

  7. Perioperative stage indicators

    Time frame: At the end of the operation

    operation time, anesthesia time, recovery time

  8. Postoperative pain

    Time frame: Six hours, 24 hours, 48 hours after surgery

    Postoperative pain (numerical rating scale (NRS))

  9. Postoperative Lung function

    Time frame: 1, 3, 5 days after surgery

    FVC, FEV1, FEV1 (% pred)

  10. Postoperative Lung function

    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.

  11. Postoperative pulmonary complications

    Time frame: 1, 3, 5 days after surgery

    european perioperative clinical outcome (EPCO)

  12. Postoperative gastrointestinal function

    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.

  13. Postoperative depression/anxiety

    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

  14. Postoperative cognitive function

    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.

  15. Time of first exercise after surgery

    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

  16. The 6-minute walking experiment

    Time frame: 30 days after surgery.

    Measure the distance covered by an individual walking for 6 minutes at the highest speed

  17. Length of stay

    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

  18. Quality of life measurement

    Time frame: the date of discharge,and Thirty days after surgery

    Use a WHOQOL-BREF scale rating to evaluate quality of life

  19. Intraoperative circulation 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

    Blood pressure

  20. Intraoperative circulation 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

    heart rate

  21. Intraoperative circulation 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

    pulse oxygen saturation

  22. Intraoperative circulation 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

    anesthesia depth index

  23. Intraoperative circulation 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

    body temperature

  24. Intraoperative circulation 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

    urine volume

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Xu, Professor

CONTACT

[email protected]

(86)-13971001596

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.