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

NCT02480088 | Completed Phase 4

• 1 other identifier: 4-2014-0583
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• number of postoperative nausea and vomiting incidence

  during postoperative 48h

Study Arms (2)

ramosetron

EXPERIMENTAL

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

Drug: Ramosetron

palonosetron

ACTIVE COMPARATOR

patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Drug: Palonosetron

Interventions

Ramosetron DRUG

ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery

ramosetron

Palonosetron DRUG

palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.

palonosetron

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20-85 yr
• undergoing spine surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron; Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 24, 2015
• Study Start: September 22, 2014
• Primary Completion: March 11, 2015
• Study Completion: March 11, 2015
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

KR (1)