Comparison of ondansetron and dexamethasone combination versus ondansetron alone for prevention of postoperative nausea and vomiting in cardiac surgery: a randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250423001

Enrollment

190

Registered

2025-04-23

Start date

2025-06-06

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Postoperative nausea and vomiting in cardiac surgery Postoperative nausea and vomiting, ondansetron, dexamethasone, cardiac surgery

Interventions

Participants receive a combination of dexamethasone 8 mg IV after induction of anesthesia and ondansetron 4 mg IV at the end of the surgery.,Participants receive a placebo (2 mL of normal saline IV) a

Experimental Drug,Active Comparator Drug

Combination group,Ondansetron group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 75 years 2. Patients scheduled for elective cardiac surgery using cardiopulmonary bypass, including coronary artery bypass graft (CABG) surgery, valve surgery, combined CABG and valve surgery, correction of congenital heart diseases, and others 3. Patients with two or more risk factors for PONV according to the Apfel risk score (female gender, non-smoker, history of PONV or motion sickness, and use of postoperative opioids) 4. Patients who provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patient with diabetes mellitus requiring insulin 2. Patients with septicemia or other severe infections 3. Patients with preoperative 12-leads electrocardiogram (EKG) showing QT prolongation (QTc > 450 ms in men, > 470 ms in women) 4. Patients taking long-term steroids, antiemetics, or opioids before surgery 5. Patients with known allergy to ondansetron, dexamethasone or fentanyl 6. Patients with neurocognitive disorders or preoperative cognitive dysfunction who are unable to appropriately report PONV symptoms 7. Patients receiving preoperative invasive mechanical ventilation 8. Patients receiving preoperative inotropic medications 9. Patients for whom the anesthesiologist decides not to use the patient-controlled analgesia (PCA) after surgery for any reason 10. Pregnant patients 11. Patients undergoing deep hypothermic circulatory arrest

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative nausea and vomiting (PONV) First 24 hours after surgery ICU nurses evaluate the participants every two hours	—

Secondary

Measure	Time frame
Severity of PONV First 24 hours after surgery Numerical rating scale (0 to 10),Onset time of PONV First 24 hours after surgery Time between ICU arrival and the first occurrence of PONV,Time to the first dose of rescue antiemetic medication First 24 hours after surgery Time between ICU arrival and the first rescue treatment of PONV,Number of doses of rescue antiemetic medication administered First 24 hours after surgery Total doses administered in 24 hours	—

Measure

Time frame

Severity of PONV First 24 hours after surgery Numerical rating scale (0 to 10),Onset time of PONV First 24 hours after surgery Time between ICU arrival and the first occurrence of PONV,Time to the first dose of rescue antiemetic medication First 24 hours after surgery Time between ICU arrival and the first rescue treatment of PONV,Number of doses of rescue antiemetic medication administered First 24 hours after surgery Total doses administered in 24 hours

—

Countries

Thailand

Contacts

Public ContactAsamaporn Puetpaiboon

Faculty of Medicine, Prince of Songkla University

asmaporn.p@psu.ac.th074451651

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026