Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

NCT04853147 | Completed Phase 3 DMC

• 1 other identifier: E2020170
• Study Type: interventional
• Target: 1,154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

C.Surgical Procedure; Gastrointestinal

Keywords

postoperative nausea and vomiting, fosaprepitant,

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (12)

• 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)

Other Outcomes (2)

• 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

Study Arms (2)

triple therapy

EXPERIMENTAL

Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered

Drug: palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl

double therapy

OTHER

double combination of Palonosetron and Dexamethasone were administered

Drug: palonosetron, dexamethasone, and 0.9% NaCl

Interventions

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,

Also known as: Triple therapy

triple therapy

palonosetron, dexamethasone, and 0.9% NaCl DRUG

palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,

Also known as: double therapy

double therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and Age ≤75 years;
• Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
• The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.

You may not qualify if:

• The American Society of Anesthesiologists (ASA) rating is \>3;
• Severe hepatic dysfunction(the score of Child-Pugh is \>9);
• With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;
• Take medications with known antiemetic properties preoperatively ;
• With mental disorder, or not be able to communicate ;
• Pregnant women or nursing mothers.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (12)

• 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.

  PMID: 25165427 BACKGROUND

• 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.

  PMID: 23560185 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.

  PMID: 28420629 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.

  PMID: 18633025 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.

  PMID: 31935249 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.

  PMID: 32925337 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.

  PMID: 10475299 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.

  PMID: 32467512 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.

  PMID: 31998020 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.

  PMID: 26408511 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.

  PMID: 23035051 BACKGROUND

• 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.

  PMID: 37423834 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yang Zhao, Doctor

  Sixth SunYetSen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: April 27, 2021
• Primary Completion: April 13, 2022
• Study Completion: October 12, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)