Opioid-free Anesthesia in VATS Lung Resection
- Conditions
- Opioid Free Anesthesia
- Interventions
- Procedure: Paravertebral block+Anterior serratus plane blockDrug: opioid free anesthesiaDrug: opioid based anesthesia
- Registration Number
- NCT04507165
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
A comparison of incidences of postoperative opioid-related adverse effects and recovery parameters in patients undergoing video-assisted thoracoscopic surgery (VATS) lung resection receiving opioid or opioid-free general anesthesia (OFA).
- Detailed Description
Video-assisted thoracoscopic surgery (VATS) lung resection is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of respiratory depression, hypotension, postoperative nausea and vomiting (PONV), dizziness, constipation and urinary retention, and more severe acute postoperative pain.
The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the primary outcome measures of the total incidence of opioid-related adverse effects (including respiratory depression, hypotension, PONV and dizziness) and secondary outcome measures of incidence of intraoperative and postoperative cardiovascular complications, pain relief, analgesic requirement , and other postoperative recovery parameters \[e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively\].
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Undergoing VATS lung resection.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Agreed to participate in the trial.
- Pregnant women
- ASA phase III or above.
- Undergoing emergency surgery.
- Planning for thoracotomy.
- Adults protected by law (under judicial protection, guardianship or supervision), people who deprived of their liberty.
- Patients who have received general anesthesia.
- Atrioventricular block, sinus node block or intraventricular block.
- Sinus bradycardia (heart rate is less than 60 beats/min).
- Preoperative hypotension (systolic blood pressure is less than 90mmHg)
- Combined with urolithiasis, Meniere syndrome, and vertebral artery stenosis
- Combined with cerebrovascular disease.
- Contraindication to NSAIDs drug.
- Allergic to anesthetics.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description opioid-free general anesthesia Paravertebral block+Anterior serratus plane block under opioid-free general anesthesia opioid-free general anesthesia opioid free anesthesia under opioid-free general anesthesia opioid based general anesthesia Paravertebral block+Anterior serratus plane block under opioid based general anesthesia opioid based general anesthesia opioid based anesthesia under opioid based general anesthesia
- Primary Outcome Measures
Name Time Method Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation The total incidence refers to the sum of the incidence of opioid-related adverse effects at 2h, 4h, 6h, 24h and 48h postoperationOpioid-related adverse effects here including respiratory depression, hypotension, PONV and dizziness.
- Secondary Outcome Measures
Name Time Method Defecation time Up to 48 hours postoperation From the operation finished to first-time defecation
Pain severity 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation Using 0-10 numerical rating scale (NRS). The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.
Dosage of opioids 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation Total dosage of opioids postoperation
Incidence of intraoperative cardiovascular complications During the operation Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor.
Incidence of postoperative cardiovascular complications Up to 30 days postoperation Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor.
Duration of tracheal intubation removing Up to 2 hours postoperation From anesthetic discontinuance to tracheal extubation
Duration of departing from PACU Up to 4 hours postoperation From tracheal extubation to Aldrete score\>9. Aldrete score is the standard for departing from PACU which includes five contents to evaluate: activity, breath, blood pressure, state of consciousness and oxygen saturation by pulse oximetry (SpO2). 2 point in total for each content. 2 point refers to the best state, whereas 0 point refers to the worst state. When a patient's total score greater than 9 who will be transferred out of PACU.
Flatus time Up to 48 hours postoperation From the operation finished to first-time exhaust
Postoperative duration of stay in hospital 30 days postoperation The duration when patients stay in hospital after surgery.
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China