Video-assisted Thoracoscopic Lung Surgery；AnesthesiaNCT06367218
Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS
A study testing opioid based strategy, opioid-free strategy and Laryngeal mask airway; Preserved spontaneous breathing in people with Video-assisted Thoracoscopic Lung Surgery；Anesthesia, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Video-assisted Thoracoscopic Lung Surgery；Anesthesia
- What is being tested?
- opioid based strategy, opioid-free strategy and Laryngeal mask airway; Preserved spontaneous breathing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Hui Xu, +8613971001596, huixu@tjh.tjmu.edu.cn
About this study
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
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.
Read the 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.
- Being tested
- opioid based strategy, opioid-free strategy, Laryngeal mask airway; Preserved spontaneous breathing, Double lumen tracheal tube; Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid based strategyDrug
Induction and maintenance of anesthesia with opioids
opioid-free strategyDrug
Esketamine was used for induction and maintenance of anesthesia
Laryngeal mask airway; Preserved spontaneous breathingProcedure or surgery
The patient used a laryngeal mask to maintain spontaneous breathing
Double lumen tracheal tube; Mechanical ventilationProcedure or surgery
The patient was mechanically ventilated using a double-lumen tracheal catheter
| Study group | Role | What they receive |
|---|---|---|
| OSB | Experimental | 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. Receives: Drug: opioid based strategy; Procedure: Laryngeal mask airway; Preserved spontaneous breathing |
| KSB | Experimental | 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. Receives: Drug: opioid-free strategy; Procedure: Laryngeal mask airway; Preserved spontaneous breathing |
| OMV | Experimental | 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. Receives: Drug: opioid based strategy; Procedure: Double lumen tracheal tube; Mechanical ventilation |
| KMV | Experimental | 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. Receives: Drug: opioid-free strategy; Procedure: Double lumen tracheal tube; Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function 30 days after surgery
FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.
Measured: 30 days after surgery
Secondary outcomes (24)
Intraoperative respiratory parameters
Airway peak pressure
Measured: 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
oxygenation index (OI=PaO2/FiO2)
Measured: 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
alveolar arterial oxygen partial pressure difference (P(A-a)DO2)
Measured: 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
respiratory index (RI=P(A-a)DO2 /PaO2)
Measured: 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
dynamic lung compliance
Measured: 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
Blood loss, intraoperative transfusion
Measured: At the end of the operation
Perioperative stage indicators
operation time, anesthesia time, recovery time
Measured: At the end of the operation
Postoperative pain
Postoperative pain (numerical rating scale (NRS))
Measured: Six hours, 24 hours, 48 hours after surgery
Postoperative Lung function
FVC, FEV1, FEV1 (% pred)
Measured: 1, 3, 5 days after surgery
Postoperative Lung function
Copd Patient Self-Assessment Test (CAT)，Scores range from 0 to 40, with ≥10 indicating the need for medical intervention.
Measured: 1, 3, 5 days after surgery
Postoperative pulmonary complications
european perioperative clinical outcome (EPCO)
Measured: 1, 3, 5 days after surgery
Postoperative gastrointestinal function
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.
Measured: Six hours, 24 hours, 48 hours after surgery
Postoperative depression/anxiety
(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
Measured: Before surgery, 2 days after surgery
Postoperative cognitive function
(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.
Measured: Before surgery, 1 day after surgery, 3 days after surgery
Time of first exercise after surgery
objective parameters included stable vital signs, no obvious bleeding tendency, NRS score less than 5 points
Measured: From the end of surgery，Until the first time of off-bed activity
The 6-minute walking experiment
Measure the distance covered by an individual walking for 6 minutes at the highest speed
Measured: 30 days after surgery.
Length of stay
The number of days spent in the hospital from the end of surgery until discharge or death
Measured: From date of surgery Until the date of discharge or death
Quality of life measurement
Use a WHOQOL-BREF scale rating to evaluate quality of life
Measured: the date of discharge，and Thirty days after surgery
Intraoperative circulation parameters
Blood pressure
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Intraoperative circulation parameters
heart rate
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Intraoperative circulation parameters
pulse oxygen saturation
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Intraoperative circulation parameters
anesthesia depth index
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Intraoperative circulation parameters
body temperature
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Intraoperative circulation parameters
urine volume
Measured: At the beginning of the operation, 30 minutes after the operation began, 1 hour, 2 hours, at the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Oct 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic Lung Surgery；AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Xu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367218
- Sponsor's protocol ID
- S036
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06367218
- Acronym / sponsor ID
- S036
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OSB | Experimental | Drug: opioid based strategy, Procedure: Laryngeal mask airway; Preserved spontaneous breathingAnesthesia 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. |
| KSB | Experimental | Drug: opioid-free strategy, Procedure: Laryngeal mask airway; Preserved spontaneous breathingAnesthesia 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. |
| OMV | Experimental | Drug: opioid based strategy, Procedure: Double lumen tracheal tube; Mechanical ventilationAnesthesia 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. |
| KMV | Experimental | Drug: opioid-free strategy, Procedure: Double lumen tracheal tube; Mechanical ventilationAnesthesia 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioid based strategyInduction and maintenance of anesthesia with opioids | Drug | OMV, OSB |
| opioid-free strategyEsketamine was used for induction and maintenance of anesthesia | Drug | KMV, KSB |
| Laryngeal mask airway; Preserved spontaneous breathingThe patient used a laryngeal mask to maintain spontaneous breathing | Procedure or surgery | KSB, OSB |
| Double lumen tracheal tube; Mechanical ventilationThe patient was mechanically ventilated using a double-lumen tracheal catheter | Procedure or surgery | KMV, OMV |
Primary outcome
Lung function 30 days after surgery
Time frame: 30 days after surgery
FEV1(% pred) at 30 days after thoracoscopic pulmonary nodule surgery.
24 secondary outcomes
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
Postoperative depression/anxiety
Time frame: Before surgery, 2 days after surgery
Postoperative cognitive function
Time frame: Before surgery, 1 day after surgery, 3 days after surgery
Time of first exercise after surgery
Time frame: From the end of surgery，Until the first time of off-bed activity
The 6-minute walking experiment
Time frame: 30 days after surgery.
Length of stay
Time frame: From date of surgery Until the date of discharge or death
Quality of life measurement
Time frame: the date of discharge，and Thirty days after surgery
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid based strategy, opioid-free strategy and Laryngeal mask airway; Preserved spontaneous breathing in people with Video-assisted Thoracoscopic Lung Surgery；Anesthesia, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Xu, Professor ((86)-13971001596, huixu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function 30 days after surgery (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.