Text Size

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
  Purpose

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


Condition Intervention
Hypotension
Shivering
Nausea and Vomiting
Vasopressor
 Drug: ramosetron
Drug: ondansetron
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ramosetron 0.3 mg
preparation of ramosetron 0.3 mg
 Drug: ramosetron
before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
Active Comparator: ondansetron 8 mg
preparation of ondansetron 8mg
 Drug: ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
Active Comparator: ondansetron 4 mg
preparation of ondansetron 4mg
 Drug: ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
Placebo Comparator: non 5-HT3 receptor antagonist
preparation of normal saline 5 ml
 Drug: placebo
before 5 minutes spinal anesthesia, injection of normal saline 5 ml

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing spinal anesthesia

Exclusion Criteria:

  • hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669213

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Wonsik Ahn, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01669213     History of Changes
Other Study ID Numbers: WSAhn_ramosetron_hypotension
Study First Received: August 10, 2012
Last Updated: August 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
5-HT3 receptor antagonist
hypotension
spinal anesthesia

Additional relevant MeSH terms:
Hypotension
Vomiting
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Anesthetics
Ondansetron
Ramosetron
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on June 18, 2013