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

NCT ID: NCT01669213

Last Updated: 2012-08-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Hypotension Shivering Nausea and Vomiting Vasopressor

Keywords

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5-HT3 receptor antagonist hypotension spinal anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ramosetron 0.3 mg

preparation of ramosetron 0.3 mg

Group Type ACTIVE_COMPARATOR

ramosetron

Intervention Type DRUG

before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg

ondansetron 8 mg

preparation of ondansetron 8mg

Group Type ACTIVE_COMPARATOR

ondansetron

Intervention Type DRUG

before 5 minutes spinal anesthesia, injection of ondansetron 8 mg

ondansetron 4 mg

preparation of ondansetron 4mg

Group Type ACTIVE_COMPARATOR

ondansetron

Intervention Type DRUG

before 5 minutes spinal anesthesia, injection of ondansetron 4 mg

non 5-HT3 receptor antagonist

preparation of normal saline 5 ml

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

before 5 minutes spinal anesthesia, injection of normal saline 5 ml

Interventions

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ramosetron

before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg

Intervention Type DRUG

ondansetron

before 5 minutes spinal anesthesia, injection of ondansetron 8 mg

Intervention Type DRUG

ondansetron

before 5 minutes spinal anesthesia, injection of ondansetron 4 mg

Intervention Type DRUG

placebo

before 5 minutes spinal anesthesia, injection of normal saline 5 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing spinal anesthesia

Exclusion Criteria

* hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wonsik Ahn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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WSAhn_ramosetron_hypotension

Identifier Type: -

Identifier Source: org_study_id