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

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Ramosetron; Drug: Palonosetron

• Registration Number: NCT02480088
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-22
• Primary Completion: 2015-03-11
• Study Completion: 2015-03-11
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-21
• Study First Posted: 2015-06-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramosetron	Ramosetron	patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting
palonosetron	Palonosetron	patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Primary Outcome Measures

Name	Time	Method
number of postoperative nausea and vomiting incidence	during postoperative 48h

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia; 🇰🇷 Seoul, Korea, Republic of