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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480088

Enrollment

300

Registered

2015-06-24

Start date

2014-09-22

Completion date

2015-03-11

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGRamosetron

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

DRUGPalonosetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
number of postoperative nausea and vomiting incidence	during postoperative 48h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026