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

NCT ID: NCT02480088

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-22

Study Completion Date

2015-03-11

Brief Summary

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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

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ramosetron

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

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

palonosetron

patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Group Type ACTIVE_COMPARATOR

Palonosetron

Intervention Type DRUG

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

Interventions

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Ramosetron

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

Intervention Type DRUG

Palonosetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine and Anesthesia

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0583

Identifier Type: -

Identifier Source: org_study_id