Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery

Study Overview
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Brief Summary
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This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.

Detailed Description
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Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.

Official Title
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The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study

Conditions
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Postoperative Nausea and Vomiting, Opioid Use, Thoracic Diseases

Intervention / Treatment
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* Procedure: Opioid-Free Anesthesia (OFA)
* Procedure: Standard general anesthesia (OA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia Exclusion Criteria: ASA classification > 4 BMI>35kg/m2 Unable to communicate before surgery Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery Anticipated intolerance to the anesthesia protocol of this study Expect prolonged mechanical ventilation after surgery Decline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid-Free Anesthesia (OFA froup)<br>Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs. | Procedure: Opioid-Free Anesthesia (OFA)<br>* Opioid-free general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.), dexmedetomidine (0.5ug/kg i.v. in 15min), and ultrasound-guided T4-5 paravertebral nerve block (0.5% Ropivacaine 20ml). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v.). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC), continuous intravenous infusion of dexmedetomidine (0.5ug/kg/h), and lidocaine (1.5mg/kg/h). Flurbiprofen (50 mg i.v.) given at the time of skin suture.<br>* Other names: Non-Opioid anesthesia (NOA);|
| Active Comparator: Standard general anesthesia (OA)<br>Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs. | Procedure: Standard general anesthesia (OA)<br>* Standard general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), sufentanil (0.3-0.4ug/kg), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v. ). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC) and continuous intravenous infusion of remifentanil (0.1-0.2ug/kg/min). Flurbiprofen (50 mg i.v.) given at the time of skin suture.<br>* Other names: Opioid-based general anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting | Assessed using Myles's simplified postoperative nausea and vomiting impact scale. The scale on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe). The score>0 is regarded as PONV occurred. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of Simplified postoperative nausea and vomiting impact scale | Assessed using Myles's simplified postoperative nausea and vomiting impact scale. The score on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching score (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe) | 24 hours after surgery | 
| Quality of post-operative recovery | Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better) | 24 hours after surgery | 
| Postoperative pain at rest and cough | Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse) | 24 hours after surgery | 
| The six minute walking test (6MWT) | Assessed by the 6MWT worksheet and report. (High scores represent better) | 48 hours after surgery |