Opioid-free Anesthesia in VATS Lung Resection

Study Overview
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Brief Summary
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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
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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].

Official Title
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The Effect of Opioid-free Anesthesia on Postoperative Analgesia-related Adverse Reactions in Lung Resection With Video-assisted Thoracoscopic Access: a Randomized Double-blind Controlled Study

Conditions
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Opioid Free Anesthesia

Intervention / Treatment
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* Procedure: Paravertebral block+Anterior serratus plane block
* Drug: opioid free anesthesia
* Drug: opioid based anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing VATS lung resection. American Society of Anesthesiologists (ASA) physical status I-II. Agreed to participate in the trial. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: opioid-free general anesthesia<br>under opioid-free general anesthesia | Procedure: Paravertebral block+Anterior serratus plane block<br>* Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by ice cube method 15 minutes after the procedure.<br>* Other names: nerve block;Drug: opioid free anesthesia<br>* Anesthesia induction: Dexmedetomidine 1µg/kg (intravenous infusion within 10min), propofol 1.5-2mg/kg (intravenous bolus), lidocaine 1.5-2mg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus), and 0.5% tetracaine 5ml for surface anesthesia of the throat. Maintenance of anesthesia: Continuous infusion of propofol and dexmedetomidine [0.4μg/(kg.h)]. The infusion rate of propofol was adjusted according to bispectral index value. Cisatracurium besylate was given as needed. Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively. Remedy: If blood pressure rises (more than 30% of the mean arterial pressure after induction), and heart rate increases (more than 30% of heart rate after induction) during skin incision, lidocaine 1.5mg/kg will be given intravenously and then be continuously infused at a rate of 1.5mg/(kg.h).<br>* Other names: OFA;|
| Active Comparator: opioid based general anesthesia<br>under opioid based general anesthesia | Procedure: Paravertebral block+Anterior serratus plane block<br>* Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by ice cube method 15 minutes after the procedure.<br>* Other names: nerve block;Drug: opioid based anesthesia<br>* Anesthesia induction: Propofol 1.5-2mg/kg (intravenous bolus), sufentanil 0.3μg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus). Maintenance of anesthesia: Continuous infusion of propofol and remifentanil. The infusion rate of propofol was adjusted according to BIS value. The infusion rate of remifentanil was 0.1-0.5µg/(kg.min) and adjusted according to the change of heart rate and blood pressure. Cisatracurium besylate was given as needed. Sufentanil 0.1μg/kg and flurbiprofen 50mg were given intravenously before the skin incision and suture respectively.<br>* Other names: Standard anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total incidence of opioid-related adverse effects of 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. | 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative cardiovascular complications | Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor. | During the operation | 
| Incidence of postoperative cardiovascular complications | Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor. | Up to 30 days postoperation | 
| Duration of tracheal intubation removing | From anesthetic discontinuance to tracheal extubation | Up to 2 hours postoperation | 
| Duration of departing from PACU | 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. | Up to 4 hours postoperation | 
| Pain severity | 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. | 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation | 
| Dosage of opioids | Total dosage of opioids postoperation | 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation | 
| Flatus time | From the operation finished to first-time exhaust | Up to 48 hours postoperation | 
| Defecation time | From the operation finished to first-time defecation | Up to 48 hours postoperation | 
| Postoperative duration of stay in hospital | The duration when patients stay in hospital after surgery. | 30 days postoperation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Free Anesthesia, Video-assisted Thoracoscopic Surgery