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Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

NCT ID: NCT04853147

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2022-10-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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C.Surgical Procedure; Gastrointestinal

Keywords

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postoperative nausea and vomiting, fosaprepitant,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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triple therapy

Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered

Group Type EXPERIMENTAL

palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl

Intervention Type DRUG

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

double therapy

double combination of Palonosetron and Dexamethasone were administered

Group Type OTHER

palonosetron, dexamethasone, and 0.9% NaCl

Intervention Type DRUG

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

Interventions

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palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl

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

Intervention Type DRUG

palonosetron, dexamethasone, and 0.9% NaCl

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

Intervention Type DRUG

Other Intervention Names

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Triple therapy double therapy

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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YangZhao

deputy director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sixth SunYetSen

Locations

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The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25165427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23560185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28420629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18633025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31935249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32925337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10475299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32467512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31998020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26408511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23035051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37423834 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E2020170

Identifier Type: -

Identifier Source: org_study_id