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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Ramosetron; Drug: Palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02480088

4-2014-0583

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

ramosetron

Experimental group

Description:

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

Treatment:

Drug: Ramosetron

palonosetron

Active Comparator group

Description:

patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Treatment:

Drug: Palonosetron