Overview

This trial is active, not recruiting.

Conditions hypotension, shivering, nausea and vomiting, vasopressor
Treatments ramosetron, ondansetron, placebo
Sponsor Seoul National University Hospital
Start date August 2012
End date December 2012
Trial size 100 participants
Trial identifier NCT01669213, WSAhn_ramosetron_hypotension

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
preparation of ramosetron 0.3 mg
ramosetron
before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
(Active Comparator)
preparation of ondansetron 8mg
ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
(Active Comparator)
preparation of ondansetron 4mg
ondansetron
before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
(Placebo Comparator)
preparation of normal saline 5 ml
placebo
before 5 minutes spinal anesthesia, injection of normal saline 5 ml

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - patients undergoing spinal anesthesia Exclusion Criteria: - hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease intake of selective serotonin reuptake inhibitor

Additional Information

Official title Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.