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Aprepitant, the NK1 Antagonist, Versus Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Minimally Invasive Wedge Resection (AKSO)----A Multicentric, Randomized-Controlled, Double-Blind, Prospective Clinical Trial

Aprepitant, the NK1 Antagonist, Versus Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Minimally Invasive Wedge Resection (AKSO)----A Multicentric, Randomized-Controlled, Double-Blind, Prospective Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075028
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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 Minimally Invasive Wedge Resection of the lung

Interventions

Aprepitant group:One hour before anesthesia induction, intravenous bolus injection of 32mg Aprepitant, equivalent to 4.4ml of Aprepitant, mixed with 5.6ml of 0.9% Sodium Chloride Solution, for a total
Ondansetron group:One hour before anesthesia induction, intravenous bolus injection of 4mg Ondansetron, equivalent to 2ml of Ondansetron, mixed with 8ml of 0.9% Sodium Chloride Solution, for a total v

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years; 2. Patients planning to undergo elective minimally invasive (VATS or RATS) wedge resection of the lung; 3. Patients scheduled to receive general anesthesia; 4. American Society of Anesthesiologists (ASA) physical status I-II; 5. Body Mass Index (BMI) between 18 and 28 kg/m² [BMI = weight(kg) / height(m)²].

Exclusion criteria

Exclusion criteria: 1. Patients with a history of previous general anesthesia; 2. Patients with a history of previous thoracic surgery; 3. Patients who have received systemic antineoplastic drug therapy in the past; 4. Patients undergoing surgeries other than wedge resection, such as segmentectomy, lobectomy, sleeve resection, etc.; 5. Patients undergoing open surgery; 6. Patients undergoing simultaneous bilateral lung wedge resection; 7. Pregnant or breastfeeding patients; 8. Patients with allergies to any of the study medications; 9. Patients who have received any sedatives, opioids, steroids, or antiemetic drugs within 24 hours before surgery; 10. Patients with a preoperative Visual Analogue Scale (VAS) score for nausea greater than 4 out of 10; 11. Patients currently taking or planning to combine medications such as rifampicin, carbamazepine, phenytoin, or other strong inducers of CYP3A4 activity; 12. Patients with moderate to severe liver dysfunction; 13. Patients who will receive anesthesia maintenance with propofol during surgery; 14. Patients undergoing routine placement of nasogastric or orogastric tubes during surgery; 15. Patients who are currently participating in or planning to participate in other clinical studies.

Design outcomes

Primary

MeasureTime frame
The complete remission rate of no vomiting and no rescue within 24 hours postoperatively.;

Secondary

MeasureTime frame
The complete remission rate of no vomiting and no rescue within 48 hours postoperatively.;The rate of no vomiting within 24 hours;The rate of no vomiting within 48 hours;The rate of no rescue within 24 hours;The rate of no rescue within 48 hours;The time to first occurrence of nausea or vomiting.;The severity of nausea within 24 hours postoperatively.;The severity of nausea within 48 hours postoperatively.;The longest duration of nausea within 24 hours postoperatively.;The longest duration of nausea within 48 hours postoperatively.;Postoperative vomiting frequency within 24 hours;Postoperative vomiting frequency within 48 hours;Length of hospital stay;Time to extubation;

Countries

China

Contacts

Public ContactFang Wentao

Shanghai Chest Hospital

vwtfang@hotmail.com+86 139 0186 7516

Outcome results

None listed

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