NCT01669213

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

August 10, 2012

Last Update Submit

August 17, 2012

Conditions

HypotensionShiveringNausea and VomitingVasopressor

Keywords

5-HT3 receptor antagonisthypotensionspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes 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.

    up to 30mins after spinal anesthesia

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine

    up to 30 min after spinal anesthesia

Study Arms (4)

ramosetron 0.3 mg

ACTIVE COMPARATOR

preparation of ramosetron 0.3 mg

Drug: ramosetron

ondansetron 8 mg

ACTIVE COMPARATOR

preparation of ondansetron 8mg

Drug: ondansetron

ondansetron 4 mg

ACTIVE COMPARATOR

preparation of ondansetron 4mg

Drug: ondansetron

non 5-HT3 receptor antagonist

PLACEBO COMPARATOR

preparation of normal saline 5 ml

Drug: placebo

Interventions

ramosetronDRUG

before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg

ramosetron 0.3 mg
ondansetronDRUG

before 5 minutes spinal anesthesia, injection of ondansetron 8 mg

ondansetron 8 mg
placeboDRUG

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

non 5-HT3 receptor antagonist

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing spinal anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

HypotensionNauseaVomiting

Interventions

ramosetronOndansetron

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 20, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

August 20, 2012

Record last verified: 2012-08

Locations

KR(1)