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Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.
This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triple therapy | Experimental | Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered |
|
| double therapy | Other | double combination of Palonosetron and Dexamethasone were administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl | Drug | palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip, |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with PONV during the first 24 postoperative hours | PONV is defined as nausea, retching or vomiting | from operation completion to 24-hour after surgery (up to 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with PONV | PONV is defined as nausea, retching or vomiting | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) |
| Proportion of participants with emetic episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of materials in blood such as hormone and metabolic | materials in blood | evaluated before surgery, at the end of surgery |
| 6-month survival rate | survival rate in 6-month after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Zhao, Doctor | Sixth SunYetSen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25165427 | Background | Moon HY, Baek CW, Choi GJ, Shin HY, Kang H, Jung YH, Woo YC, Kim JY, Park SG. Palonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomised trial. BMC Anesthesiol. 2014 Aug 10;14:68. doi: 10.1186/1471-2253-14-68. eCollection 2014. | |
| 23560185 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2021 |
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|
| palonosetron, dexamethasone, and 0.9% NaCl | Drug | palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip, |
|
|
Emetic episodes are defined as retching or vomiting or both
| calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) |
| Proportion of participants with nausea | Nausea is defined as a feeling of the urge to vomit | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) |
| Proportion of participants with rescue antiemetic medication | Rescue antiemetic medication | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) |
| The severity of PONV | The severity of PONV is evaluated by a PONV impact scale score. Nausea intensity is scored as 1 ,2 ,3. In addition, vomiting intensity is scored as the number of vomits (0-2, or 3 if three or more vomits). Both scores together to obtain the PONV impact scale score | calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery) |
| Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours) | The QoR-15 comprises five subscales: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR. | evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery) |
| Pain scores | Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10). | evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery) |
| Time to first flatus after surgery | Time length between operation completion and the first flatus | evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery) |
| Time to first defecation after surgery | Time length between operation completion and the first defecation | evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery |
| Time to fulfill the criteria of hospital discharge (recovery time) | The ideal time point for discharge, which is also considered as recovery time. | from operation completion to fulfill the criteria of hospital discharge(expected 6 days ) |
| Health related quality of life | Health related quality of life is measured by EQ-5D. Each EQ-5D health state can be coded into a five-digit number using the numbers 1 , 2 , and 3 to indicate the functional levels of the five dimensions. | evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days） |
| Proportion of patients with adverse events (up to 30 days after surgery) | adverse events | from drug administration to 30 days (30 days) |
| 6-month after surgery |
| Lim CS, Ko YK, Kim YH, Park SI, Kim JK, Kim MJ, Kim HJ. Efficacy of the oral neurokinin-1 receptor antagonist aprepitant administered with ondansetron for the prevention of postoperative nausea and vomiting. Korean J Anesthesiol. 2013 Mar;64(3):212-7. doi: 10.4097/kjae.2013.64.3.212. Epub 2013 Mar 19. |
| 28420629 | Background | DREAMS Trial Collaborators and West Midlands Research Collaborative. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). BMJ. 2017 Apr 18;357:j1455. doi: 10.1136/bmj.j1455. |
| 18633025 | Background | Rojas C, Stathis M, Thomas AG, Massuda EB, Alt J, Zhang J, Rubenstein E, Sebastiani S, Cantoreggi S, Snyder SH, Slusher B. Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg. 2008 Aug;107(2):469-78. doi: 10.1213/ane.0b013e318172fa74. |
| 31935249 | Background | Gouveia de Araujo Ferreira N, Cavalcanti IL, Assad AR, Barrucand L, Braga ELC, Vercosa N. A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients. PLoS One. 2020 Jan 14;15(1):e0227490. doi: 10.1371/journal.pone.0227490. eCollection 2020. |
| 32925337 | Background | Wang EHZ, Sunderland S, Edwards NY, Chima NS, Yarnold CH, Schwarz SKW, Coley MA. A Single Prophylactic Dose of Ondansetron Given at Cessation of Postoperative Propofol Sedation Decreases Postoperative Nausea and Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial. Anesth Analg. 2020 Oct;131(4):1164-1172. doi: 10.1213/ANE.0000000000004730. |
| 10475299 | Background | Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022. |
| 32467512 | Background | Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. |
| 31998020 | Background | Amirshahi M, Behnamfar N, Badakhsh M, Rafiemanesh H, Keikhaie KR, Sheyback M, Sari M. Prevalence of postoperative nausea and vomiting: A systematic review and meta-analysis. Saudi J Anaesth. 2020 Jan-Mar;14(1):48-56. doi: 10.4103/sja.SJA_401_19. Epub 2020 Jan 6. |
| 26408511 | Background | Hooper VD. SAMBA Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: An Executive Summary for Perianesthesia Nurses. J Perianesth Nurs. 2015 Oct;30(5):377-82. doi: 10.1016/j.jopan.2015.08.009. No abstract available. |
| 23035051 | Background | Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3. |
| 41062989 | Derived | Shi J, Huang Y, Han J, Zhang S, Cheng X, Luo T. Development and validation of a machine learning-based prediction model for prolonged length of stay after laparoscopic gastrointestinal surgery: a secondary analysis of the FDP-PONV trial. BMC Gastroenterol. 2025 Oct 8;25(1):703. doi: 10.1186/s12876-025-04330-y. |
| 37423834 | Derived | Huang Q, Wang F, Liang C, Huang Y, Zhao Y, Liu C, Lin C, Zhang L, Zhou S, Wang Q, Li S, Gong R, Wu Q, Gu Y, Zhang J, Luo T, Wang W, Zhang S, Bizo Mailoga N, Wang K, Jin S, Zhao Y. Fosaprepitant for postoperative nausea and vomiting in patients undergoing laparoscopic gastrointestinal surgery: a randomised trial. Br J Anaesth. 2023 Oct;131(4):673-681. doi: 10.1016/j.bja.2023.06.029. Epub 2023 Jul 7. |
| Jun 10, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| 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 |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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