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

Primary Purpose

Hypotension, Shivering, Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ramosetron
ondansetron
ondansetron
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring 5-HT3 receptor antagonist, hypotension, spinal anesthesia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing spinal anesthesia

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ramosetron 0.3 mg

ondansetron 8 mg

ondansetron 4 mg

non 5-HT3 receptor antagonist

Arm Description

preparation of ramosetron 0.3 mg

preparation of ondansetron 8mg

preparation of ondansetron 4mg

preparation of normal saline 5 ml

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
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.

Full Information

First Posted
August 10, 2012
Last Updated
August 17, 2012
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01669213
Brief Title
Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension
Official Title
Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Shivering, Nausea and Vomiting, Vasopressor
Keywords
5-HT3 receptor antagonist, hypotension, spinal anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ramosetron 0.3 mg
Arm Type
Active Comparator
Arm Description
preparation of ramosetron 0.3 mg
Arm Title
ondansetron 8 mg
Arm Type
Active Comparator
Arm Description
preparation of ondansetron 8mg
Arm Title
ondansetron 4 mg
Arm Type
Active Comparator
Arm Description
preparation of ondansetron 4mg
Arm Title
non 5-HT3 receptor antagonist
Arm Type
Placebo Comparator
Arm Description
preparation of normal saline 5 ml
Intervention Type
Drug
Intervention Name(s)
ramosetron
Intervention Description
before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
Intervention Type
Drug
Intervention Name(s)
ondansetron
Intervention Description
before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
Intervention Type
Drug
Intervention Name(s)
ondansetron
Intervention Description
before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
before 5 minutes spinal anesthesia, injection of normal saline 5 ml
Primary Outcome Measure Information:
Title
prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
Description
comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
Time Frame
up to 30mins after spinal anesthesia
Secondary Outcome Measure Information:
Title
prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
Description
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.
Time Frame
up to 30mins after spinal anesthesia
Other Pre-specified Outcome Measures:
Title
occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine
Time Frame
up to 30 min after spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing spinal anesthesia Exclusion Criteria: hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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