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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01669213
• Other study ID #: WSAhn_ramosetron_hypotension
• 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

• Hypotension
• Nausea and Vomiting
• Shivering
• Vasopressor

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