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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02480088
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 53.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Ramosetron; Drug: Palonosetron	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Actual Study Start Date: Sep 22, 2014
• Actual Primary Completion Date: Mar 11, 2015
• Actual Study Completion Date: Mar 11, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ramosetron patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting	Drug: Ramosetron; ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery
Active Comparator: palonosetron patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting	Drug: Palonosetron; palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.

Outcome Measures

Primary Outcome Measures

1. number of postoperative nausea and vomiting incidence [during postoperative 48h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine and Anesthesia	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02480088
• Other Study ID Numbers: 4-2014-0583
• First Posted: Jun 24, 2015
• Last Update Posted: Oct 27, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Palonosetron; Ramosetron

Study Results

No Results Posted as of Oct 27, 2017