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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
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

August 10, 2012
August 17, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01669213 on ClinicalTrials.gov Archive Site
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.
Same as current
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 ]
Same as current
 
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypotension
  • Shivering
  • Nausea and Vomiting
  • Vasopressor
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
August 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing spinal anesthesia

Exclusion Criteria:

  • hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01669213
WSAhn_ramosetron_hypotension
Not Provided
Wonsik Ahn, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP