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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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramosetron

Palonosetron

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Anesthesiology and Pain Medicine and Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ramosetron

palonosetron

Arm Description

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Outcomes

Primary Outcome Measures

number of postoperative nausea and vomiting incidence

Secondary Outcome Measures

Full Information

NCT ID

NCT02480088

First Posted

June 17, 2015

Last Updated

October 25, 2017

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02480088

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 22, 2014 (Actual)

Primary Completion Date

March 11, 2015 (Actual)

Study Completion Date

March 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ramosetron

Arm Type

Experimental

Arm Description

patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting

Arm Title

palonosetron

Arm Type

Active Comparator

Arm Description

patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting

Intervention Type

Drug

Intervention Name(s)

Ramosetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Intervention Description

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

Primary Outcome Measure Information:

Title

number of postoperative nausea and vomiting incidence

Time Frame

during postoperative 48h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine and Anesthesia

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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