Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

• Status: Completed
• Trial end date: 2015-03-11
• Target enrollment: 0
• Participant gender: All

Summary

Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Palonosetron; Ramosetron

Criteria

Inclusion Criteria:

• Patients aged 20-85 yr

• undergoing spine surgery

Exclusion Criteria:

• Taking steroids or opioids preoperatively

• GI motility disorder

• Uncontrolled diabetes

• Severe renal or hepatic disease

• Transfer to ICU postoperatively

• Obesity (BMI>35 kg/m2)

• Use of antiemetic agent within 24 h preoperatively

• Pregnancy

• Psychiatric disease

• Drug or alcohol abuser

• Malignancy