Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-Free Anesthesia (OFA froup) | Experimental | Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs. |
|
| Standard general anesthesia (OA) | Active Comparator | Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-Free Anesthesia (OFA) | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative length of hospital stay | Length of hospital stay in days | Up to 7 days after surgery |
| Postoperative anesthesia care unit (PACU) duration | PACU duration in minutes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22290456 | Result | Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. | |
| 29397134 | Result | Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. |
Not provided
Not provided
The extent to which data is shared will be determined based on the progress of the study and local healthcare policies
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard general anesthesia (OA) | Procedure | 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. |
|
|
| 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 |
| Up to 4 hours after surgery |
| Intraoperative complications | Assessed according to ClassIntra complication classifications | From entering to leaving the operating room, an average of 4 hours |
| Postoperative Complications | Assessed according to Clavien-Dindo surgical complication classifications | within 7 days after surgery or discharge |
| Health and well-being after surgery | Assessed according to the Short-Form (SF-36) health survey, included 36 items groups in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health. | 6 month after surgery |
| 32843333 | Result | Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917. |
| 15273542 | Result | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 41776687 | Derived | Yan X, Liang C, Guo M, Jiang J, Ji Y, Wu AS, Wei CW. Effect of EEG-guided opioid-free anesthesia on perioperative blood glucose variation in patients undergoing video-assisted thoracic surgery: a secondary analysis of a randomized controlled study. Perioper Med (Lond). 2026 Mar 3;15(1):36. doi: 10.1186/s13741-026-00666-5. |
| 39923016 | Derived | Yan X, Liang C, Jiang J, Ji Y, Wu AS, Wei CW. Effects of balanced opioid-free anesthesia on post-operative nausea and vomiting in patients undergoing video-assisted thoracic surgery: a randomized trial. BMC Anesthesiol. 2025 Feb 8;25(1):62. doi: 10.1186/s12871-025-02938-x. |
| 38124084 | Derived | Yan X, Liang C, Jiang J, Ji Y, Wu A, Wei C. Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial. Trials. 2023 Dec 20;24(1):819. doi: 10.1186/s13063-023-07859-z. |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided