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Comparison of Aprepitant and Ondansetron for Postoperative Nausea and Vomiting after Laparoscopic Cholecystectomy

Comparison of Aprepitant and Ondansetron for Postoperative Nausea and Vomiting after Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108960
Enrollment
Unknown
Registered
2025-09-09
Start date
2025-09-12
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Postoperative nausea and vomiting after laparoscopic cholecystectomy

Interventions

Aprepitant Injection Group (Group T):Administer 32 mg of Aprepitant (i.e., 4.4 ml of Aprepitant mixed with 5.6 ml of 0.9% saline, totaling 10 ml) via intravenous push within one hour before anesthesia
Ondansetron hydrochloride group (Group C):Administer 4 mg of Ondansetron by intravenous push (i.e., 2 ml of Ondansetron diluted with 8 ml of 0.9% saline, totaling 10 ml) within 1 hour prior to anesthe

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 80 years; 2. Patients planning to undergo elective laparoscopic cholecystectomy; 3. Patients planning to receive total intravenous anesthesia; 4. American Society of Anesthesiologists (ASA) physical status classifications I to III; 5. Body Mass Index (BMI) between 18 and 28 kg/m^2;

Exclusion criteria

Exclusion criteria: 1. Patients who have taken known antiemetic drugs before surgery; 2. Patients who are pregnant or breastfeeding; 3. Patients allergic to any study medication; 4. Patients with a preoperative VAS score for nausea greater than 4 (out of 10); 5. Patients currently taking or planning to take drugs such as rifampicin, carbamazepine, phenytoin, or other strong CYP3A4 inducers; 6. Patients with moderate to severe liver dysfunction; 7. Patients with a history of neurological or psychiatric disorders; 8. Uncooperative patients; 9. Patients experiencing severe surgical complications perioperatively; 10. Patients who are difficult to communicate or cooperate with;

Design outcomes

Primary

MeasureTime frame
Complete response rate (CR rate) within 24 hours post-operation with no vomiting and no rescue.;

Secondary

MeasureTime frame
Complete response rate (CR rate) within48 hours post-operation with no vomiting and no rescue.;Severity of postoperative nausea and vomiting;Pain intensity (VAS);Quality of Recovery (QoR-15) two days after surgery;

Countries

China

Contacts

Public ContactZhongyun Wang

The First Affiliated Hospital with Nanjing Medical University

zywang1970@126.com+86 139 1391 6609

Outcome results

None listed

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