Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS

NCT ID: NCT06367218

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-08-01

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.

Conditions

Video-assisted Thoracoscopic Lung Surgery；Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

OSB

Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.

Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.

Group Type: EXPERIMENTAL

opioid based strategy

Intervention Type: DRUG

Induction and maintenance of anesthesia with opioids

Laryngeal mask airway; Preserved spontaneous breathing

Intervention Type: PROCEDURE

The patient used a laryngeal mask to maintain spontaneous breathing

KSB

Anesthesia was induced by intravenous injection of Sufentanil 0.1 µg/kg and propofol 2 mg /kg. The patient was placed with a laryngeal mask airway, connected to an anesthetic ventilator with spontaneous breathing mode. Anesthesia was maintained with propofol (5 mg/kg/h) and remifentanil (0.01 µg/kg/min) first, and then adjusted according to the depth of anesthesia.

Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance. A mixture of 5 ml of 2% lidocaine and 5 ml of 0.5% ropivacaine was sprayed on the surface of the visceral pleura after thoracic cavity opening. The vagal and phrenic nerve trunks were blocked with 2 ml of the mixture.

Group Type: EXPERIMENTAL

opioid-free strategy

Intervention Type: DRUG

Esketamine was used for induction and maintenance of anesthesia

Laryngeal mask airway; Preserved spontaneous breathing

Intervention Type: PROCEDURE

The patient used a laryngeal mask to maintain spontaneous breathing

OMV

Anesthesia was induced by intravenous sufentanil injection of 0.5 μg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-lumen bronchial tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with initial intravenous pump of propofol (5 mg/kg/h) and remifentanil (0.1 μg/kg/min) first , and then adjusted according to the depth of anesthesia.

Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.

Group Type: EXPERIMENTAL

opioid based strategy

Intervention Type: DRUG

Induction and maintenance of anesthesia with opioids

Double lumen tracheal tube; Mechanical ventilation

Intervention Type: PROCEDURE

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

KMV

Anesthesia was induced by intravenous injection of esketamine 0.5 mg/kg. Propofol 2 mg/kg and rocuronium 0.9 mg/kg were subsequently administered intravenously. After rocuronium took effect, double-chamber tracheal tube intubation was performed under the guidance of video laryngoscope, and fixed after the bronchoscopic examination, anesthesia ventilator was connected for mechanical ventilation, tidal volume was 6 mL/kg (ideal body weight), respiratory rate was 12-16 times /min, and end-expiratory partial pressure of carbon dioxide was maintained at 35-45 mmHg. Intraoperative anesthesia was maintained with the initial intravenous pump of propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h) first , and then adjusted according to the depth of anesthesia. Paravertebral nerve blocks were performed at T4 and T6 levels with ropivacaine (0.5%, 10 ml) under ultrasound guidance.

Group Type: EXPERIMENTAL

opioid-free strategy

Intervention Type: DRUG

Esketamine was used for induction and maintenance of anesthesia

Double lumen tracheal tube; Mechanical ventilation

Intervention Type: PROCEDURE

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

Interventions

opioid based strategy

Induction and maintenance of anesthesia with opioids

Intervention Type: DRUG

opioid-free strategy

Esketamine was used for induction and maintenance of anesthesia

Intervention Type: DRUG

Laryngeal mask airway; Preserved spontaneous breathing

The patient used a laryngeal mask to maintain spontaneous breathing

Intervention Type: PROCEDURE

Double lumen tracheal tube; Mechanical ventilation

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hui Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Xu, Professor

Role: CONTACT

huixu@tjh.tjmu.edu.cn

(86)-13971001596

Facility Contacts

Hui Xu

Role: primary

huixu@tjh.tjmu.edu.cn

+8613971001596

Other Identifiers

S036

Identifier Type: -

Identifier Source: org_study_id