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

Study Overview

• Status: Unknown
• Conditions: Hypotension; Nausea and Vomiting; Vasopressor; Shivering
• Intervention / Treatment: Drug: ramosetron; Drug: ondansetron; Drug: ondansetron; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing spinal anesthesia

Exclusion Criteria:

• hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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; Drug: ondansetron; before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
ACTIVE_COMPARATOR: ondansetron 4 mg; preparation of ondansetron 4mg	Drug: ondansetron; before 5 minutes spinal anesthesia, injection of ondansetron 8 mg; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine	up to 30 min after spinal anesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (ESTIMATE): August 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: spinal anesthesia; hypotension; 5-HT3 receptor antagonist
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms, Digestive; Vomiting; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron; Ramosetron
• Other Study ID Numbers: WSAhn_ramosetron_hypotension