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An exploratory study of the efficacy and safety of aprepitant and ondansetron alone or in combination in the prevention of nausea and vomiting after thyroid cancer surgery

An exploratory study of the efficacy and safety of aprepitant and ondansetron alone or in combination in the prevention of nausea and vomiting after thyroid cancer surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089337
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-15
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid cancer

Interventions

Ondansetron Formation:8 mg of ondansetron was administered orally 1 hour before anesthesia, followed by two doses of the drug at 8-hour intervals
The Aprepitane Group:Aprepitant 125 mg orally 1 hour before anesthesia and 80mg orally once daily on the morning of the 2nd and 3rd day after surgery (day 1 on the day of surgery)
Combination group:Aprepitant 125 mg plus 8 mg ondansetron was administered orally 1 hour before anesthesia, followed by ondansetron twice every 8 hours, and Aprepitant 80mg once daily on the morning o

Sponsors

First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 18-80 years; 2) Voluntarily join the study and sign the informed consent; 3) Patients diagnosed with thyroid cancer requiring surgical treatment;

Exclusion criteria

Exclusion criteria: 1) The patient has a history of depression, chronic pain, islet dependent diabetes I or II, and severe vomiting; 2) Previous history of thyroid or neck surgery; 3) Sternotomy is expected to be performed; 4) Long-term hormone use history, immunosuppressive treatment period; 5) Voice has changed before surgery or laryngoscopy confirms vocal cord paralysis; 6) Pregnant or breastfeeding patients; 7) Patients who are allergic to any investigational drug; 8) Received any sedation, hypnosis, anti-anxiety drugs, opioids, steroids in the 24 hours prior to surgery Or other anti-emetic drugs; 9) is taking or planning to take in combination such as rifampicin, carbamazepine, phenytoin or other strong induction CYP3A4 active drug; 10) Combined with other malignant tumors; 11) Patients with hypothyroid function; 12) Are or plan to participate in other clinical investigators.

Design outcomes

Primary

MeasureTime frame
Complete response rate with no vomiting and no rescue within 24 hours after surgery (CR rate);

Secondary

MeasureTime frame
Complete response rate with no vomiting and no rescue within 48 hours after surgery (CR rate);There was no vomiting rate in 24h and 48h;There is no rescue rate within 24h and 48h;When vomiting or nausea first occurs;Evaluation of nausea within 24h and 48h after surgery;The number of postoperative vomiting within 24h and 48h;

Countries

China

Contacts

Public ContactYin detao

First Affiliated Hospital of Zhengzhou University

detaoyin@zzu.edu.cn+86 136 9371 7963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026