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NCT Number: NCT06697782

Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer

The vast majority of patients treated prophylactically with "first-line" antiemetics in the 5-hydroxytryptamine (5-HT3) receptor antagonist class still have significant PONV. Combination therapies with different pharmacologic bases have the potential to reduce the incidence of PONV. This study is a multicenter, three-arm, prospective study to evaluate the efficacy and safety of aprepitant and ondansetron, monotherapy or in combination, in the prevention of nausea and vomiting after surgery for thyroid cancer.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

About this study

Postoperative nausea and vomiting (PONV) is the most common complication after surgery, especially thyroidectomy, and the incidence of PONV can be as high as 80% without the administration of prophylactic antiemetics. Currently, available prophylactic interventions for PONV, especially monotherapy, lack universal efficacy. Combination therapy with a different pharmacologic basis has the potential to reduce the incidence of PONV. Previous studies using various 5-HT3 receptor antagonists in combination with aprepitant have shown promising results in reducing the incidence of PONV. The present study is a multicenter, three-arm, prospective study designed to evaluate the efficacy and safety of aprepitant and ondansetron, alone or in combination, in the prevention of postoperative nausea and vomiting in thyroid cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-80 years;
  • Voluntary enrollment in the study and signing the informed consent form;
  • Diagnosed with thyroid cancer and needing surgical treatment;

Exclusion criteria

  • Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
  • history of prior thyroid or neck surgery;
  • Cases in which surgery requiring sternotomy is anticipated;
  • History of long-term hormone use, period of immunosuppressive therapy;
  • pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
  • Pregnant or breastfeeding patients;
  • Patients who are allergic to any of the study medications;
  • Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;
  • Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;
  • patients with other malignant tumors;
  • Patients with hypothyroidism;
  • Participating or planning to participate in other clinical studies.

Treatment and study plan

Ondansetron 8mg

Drug

Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter

Other names: AD

Aprepitant 125 mg

Drug

Patients in the aprepitant group received 125 mg of aprepitant orally 1 hour before anesthesia and 80 mg orally once daily in the morning of postoperative days 2 and 3 (the day of the surgery was day 1)

Other names: AR

Primary outcomes

  1. Complete remission rate (CR rate)

    Time frame: Within 24 hours after surgery

    Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution

Secondary outcomes

  1. Complete remission rate (CR rate)

    Time frame: Within 48 hours after surgery

    Complete remission rate (CR rate) without vomiting within 48h postoperatively and without resolution

  2. Rate of no vomiting

    Time frame: Within 24 and 48 hours after surgery

    Rate of no vomiting within 24h, 48h

  3. Incidence of adverse events and serious adverse events

    Time frame: up to 24 weeks

    Adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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