ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01669213
Recruitment Status : Unknown
Verified August 2012 by Wonsik Ahn, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Wonsik Ahn, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Hypotension Shivering Nausea and Vomiting Vasopressor Drug: ramosetron Drug: ondansetron Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ondansetron

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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:
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669213


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

Responsible Party: Wonsik Ahn, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01669213     History of Changes
Other Study ID Numbers: WSAhn_ramosetron_hypotension
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Vomiting
Hypotension
Signs and Symptoms, Digestive
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Ondansetron
Ramosetron
Central Nervous System Depressants
Physiological Effects of Drugs
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