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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01669213
Enrollment
100
Registered
2012-08-20
Start date
2012-08-31
Completion date
2013-08-31
Last updated
2012-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Nausea and Vomiting, Shivering, Vasopressor

Keywords

5-HT3 receptor antagonist, hypotension, spinal anesthesia

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

Interventions

DRUGramosetron

before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg

DRUGondansetron

before 5 minutes spinal anesthesia, injection of ondansetron 8 mg

DRUGplacebo

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing spinal anesthesia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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 anesthesiacomparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.

Secondary

MeasureTime frameDescription
prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressureup to 30mins after spinal anesthesiacomparasion 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.

Other

MeasureTime frame
occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropineup to 30 min after spinal anesthesia

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026