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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01669213
Other study ID # WSAhn_ramosetron_hypotension
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 10, 2012
Last updated August 17, 2012
Start date August 2012
Est. completion date August 2013

Study information

Verified date August 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date August 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
ramosetron
before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
placebo
before 5 minutes spinal anesthesia, injection of normal saline 5 ml

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine up to 30 min after spinal anesthesia No
Primary 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 No
Secondary 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. up to 30mins after spinal anesthesia No
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