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

The First Affiliated Hospital of Zhengzhou University600 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

600

Conditions

Thyroid Cancer

Interventions

Ondansetron 8mgDRUG

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

Aprepitant 125 mgDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 18-80 years; 2. Voluntary enrollment in the study and signing the informed consent form; 3. Diagnosed with thyroid cancer and needing surgical treatment; Exclusion Criteria: 1. Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting; 2. history of prior thyroid or neck surgery; 3. Cases in which surgery requiring sternotomy is anticipated; 4. History of long-term hormone use, period of immunosuppressive therapy; 5. pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis; 6. Pregnant or breastfeeding patients; 7. Patients who are allergic to any of the study medications; 8. Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure; 9. Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity; 10. patients with other malignant tumors; 11. Patients with hypothyroidism; 12. Participating or planning to participate in other clinical studies.

Outcomes

Primary Outcomes

Complete remission rate (CR rate)

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

Time frame: Within 24 hours after surgery

Secondary Outcomes

Complete remission rate (CR rate)

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

Time frame: Within 48 hours after surgery

Rate of no vomiting

Rate of no vomiting within 24h, 48h

Time frame: Within 24 and 48 hours after surgery

Incidence of adverse events and serious adverse events

Adverse events and serious adverse events

Time frame: up to 24 weeks