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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02480088
Other study ID # 4-2014-0583
Secondary ID
Status Completed
Phase Phase 4
First received June 17, 2015
Last updated October 25, 2017
Start date September 22, 2014
Est. completion date March 11, 2015

Study information

Verified date October 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 11, 2015
Est. primary completion date March 11, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ramosetron
ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery
Palonosetron
palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine and Anesthesia Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of postoperative nausea and vomiting incidence during postoperative 48h
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