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

Postoperative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480088
• Other study ID #: 4-2014-0583
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2015
• Last updated: October 25, 2017
• Start date: September 22, 2014
• Est. completion date: March 11, 2015

Study information

• Verified date: October 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 11, 2015
• Est. primary completion date: March 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Ramosetron
ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery
• Palonosetron
palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of postoperative nausea and vomiting incidence		during postoperative 48h