Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery
Sponsor study identifier
interventional
1,154
1 country
1
Study Start
April 27, 2021
Actual (reported)Primary Completion
April 13, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2021
Actual (reported)April 21, 2021
Actual (reported)April 27, 2021
Actual (reported)April 13, 2022
Actual (reported)October 12, 2022
Actual (reported)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)
Proportion of participants with PONV
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with emetic episodes
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with nausea
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
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
The severity of PONV
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Concentration of materials in blood such as hormone and metabolic
evaluated before surgery, at the end of surgery
6-month survival rate
6-month after surgery
Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered
double combination of Palonosetron and Dexamethasone were administered
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
palonosetron, dexamethasone, and 0.9% NaCl
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordThe Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
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.
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.
Yang Zhao, Doctor
Sixth SunYetSen
1,154 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2021
First Posted
April 21, 2021
Study Start
April 27, 2021
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
April 13, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)Last Updated
December 29, 2022
Record last verified: 2022-12
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