Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension

Not Applicable

• Conditions: Hypotension; Shivering; Nausea and Vomiting; Vasopressor
• Interventions: Drug: ramosetron; Drug: ondansetron; Drug: placebo

• Registration Number: NCT01669213
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3 receptor antagonists on prevention of hypotension after spinal anesthesia

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-17
• Last Update Submitted: 2012-08-17
• Study First Posted: 2012-08-20
• Last Update Posted: 2012-08-20
• Primary Completion: 2012-12
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients undergoing spinal anesthesia

Exclusion Criteria

• hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ramosetron 0.3 mg	ramosetron	preparation of ramosetron 0.3 mg
ondansetron 8 mg	ondansetron	preparation of ondansetron 8mg
ondansetron 4 mg	ondansetron	preparation of ondansetron 4mg
non 5-HT3 receptor antagonist	placebo	preparation of normal saline 5 ml

Primary Outcome Measures

Name	Time	Method
prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.	up to 30mins after spinal anesthesia	comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.

Secondary Outcome Measures

Name	Time	Method
prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure	up to 30mins after spinal anesthesia	comparasion of significantly difference in the gap between baseline systolic arterial pressure and lowest systolic arterial pressure measured during 30 minutes after spinal anesthesia and the gap between baseline diastolic arterial pressure and lowest diastolic arterial pressure measured during 30 minutes after spinal anesthesia.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of