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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Wonsik Ahn, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01669213

First received: August 10, 2012

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 10, 2012
Last Updated Date	August 17, 2012
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 17, 2012)	prevention of hypotension by calcaulation 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 ] [ Designated as safety issue: No ] comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01669213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 17, 2012)	prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure [ Time Frame: up to 30mins after spinal anesthesia ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: August 17, 2012)	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 ] [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension
Official Title ^ICMJE	Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After 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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Hypotension Shivering Nausea and Vomiting Vasopressor
Intervention ^ICMJE	Drug: ramosetron before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg Drug: ondansetron before 5 minutes spinal anesthesia, injection of ondansetron 8 mg Drug: ondansetron before 5 minutes spinal anesthesia, injection of ondansetron 4 mg Drug: placebo before 5 minutes spinal anesthesia, injection of normal saline 5 ml
Study Arm (s)	Active Comparator: ramosetron 0.3 mg preparation of ramosetron 0.3 mg Intervention: Drug: ramosetron Active Comparator: ondansetron 8 mg preparation of ondansetron 8mg Intervention: Drug: ondansetron Active Comparator: ondansetron 4 mg preparation of ondansetron 4mg Intervention: Drug: ondansetron Placebo Comparator: non 5-HT3 receptor antagonist preparation of normal saline 5 ml Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	August 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients undergoing spinal anesthesia Exclusion Criteria: hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
Gender	Both
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01669213
Other Study ID Numbers ^ICMJE	WSAhn_ramosetron_hypotension
Has Data Monitoring Committee	Not Provided
Responsible Party	Wonsik Ahn, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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