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C.Surgical Procedure; GastrointestinalPhase 3NCT04853147

Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

A Phase 3 study testing palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl and palonosetron, dexamethasone, and 0.9% NaCl in people with C.Surgical Procedure; Gastrointestinal, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
C.Surgical Procedure; Gastrointestinal
What is being tested?
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl and palonosetron, dexamethasone, and 0.9% NaCl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,154 participants
Where
1 siteChina
Study dates
27 Apr 2021to 12 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl, palonosetron, dexamethasone, and 0.9% NaCl
Keywords
postoperative nausea and vomiting, fosaprepitant,
Medical subject headings
Postoperative Nausea and Vomiting, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaClDrug

    Also called Triple therapy

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

  • palonosetron, dexamethasone, and 0.9% NaClDrug

    Also called double therapy

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

Study groups in NCT04853147
Study groupRoleWhat they receive
triple therapyExperimentalTriple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered
Receives: Drug: palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
double therapyOtherdouble combination of Palonosetron and Dexamethasone were administered
Receives: Drug: palonosetron, dexamethasone, and 0.9% NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with PONV during the first 24 postoperative hours

    PONV is defined as nausea, retching or vomiting

    Measured: from operation completion to 24-hour after surgery (up to 24 hours)

Secondary outcomes (12)

  1. Proportion of participants with PONV

    PONV is defined as nausea, retching or vomiting

    Measured: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)

  2. Proportion of participants with emetic episodes

    Emetic episodes are defined as retching or vomiting or both

    Measured: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)

  3. Proportion of participants with nausea

    Nausea is defined as a feeling of the urge to vomit

    Measured: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)

  4. Proportion of participants with rescue antiemetic medication

    Rescue antiemetic medication

    Measured: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)

  5. 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

    Measured: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)

  6. 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.

    Measured: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)

  7. Pain scores

    Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10).

    Measured: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)

  8. Time to first flatus after surgery

    Time length between operation completion and the first flatus

    Measured: evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)

  9. Time to first defecation after surgery

    Time length between operation completion and the first defecation

    Measured: evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery

  10. Time to fulfill the criteria of hospital discharge (recovery time)

    The ideal time point for discharge, which is also considered as recovery time.

    Measured: from operation completion to fulfill the criteria of hospital discharge(expected 6 days )

  11. 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.

    Measured: evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）

  12. Proportion of patients with adverse events (up to 30 days after surgery)

    adverse events

    Measured: from drug administration to 30 days (30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start27 Apr 2021
  3. Primary completion13 Apr 2022
  4. Study completion12 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04853147
Sponsor's protocol ID
E2020170
Status last verified
Dec 2022
First submitted
20 Apr 2021
Last updated
29 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25165427

  • 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.

    PubMed 23560185

  • 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.

    PubMed 28420629

  • 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.

    PubMed 18633025

  • 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.

    PubMed 31935249

  • 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.

    PubMed 32925337

  • 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.

    PubMed 10475299

  • 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.

    PubMed 32467512

  • 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.

    PubMed 31998020

  • 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.

    PubMed 26408511

  • 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.

    PubMed 23035051

  • 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.

    PubMed 41062989

  • 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.

    PubMed 37423834

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl and palonosetron, dexamethasone, and 0.9% NaCl in people with C.Surgical Procedure; Gastrointestinal, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with PONV during the first 24 postoperative hours (time frame: from operation completion to 24-hour after surgery (up to 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04853147, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.

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