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Study aim
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Comparison of the effect of intravenous ondansetron and granistron with placebo on hemodynamic variables in women candidates for cesarean section under spinal anesthesia
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 is performed on 60 patients. Random allocation software version 1.0 is used for randomization under Windows.
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Settings and conduct
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This study is performed on women candidates for cesarean section under spinal anesthesia in Kosar operating room of Shahid Sadoughi Hospital in Yazd. Prior to spinal anesthesia, the study drug or placebo is injected intravenously and then hemodynamic variables are measured and recorded during surgery and during recovery. This study is double-blind and neither the researcher nor the patient knows the type of drug prescribed, so that the drugs are prepared and coded in three identical syringes and the third person injects the drug for the patient based on the specified code.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women aged 20-35 years, Class I ASA, non-emergency cesarean section, spinal anesthesia Non-inclusion criteria: dissatisfaction with the study, diabetes, preeclampsia and eclampsia, severe heart, lung, kidney and liver disease, drug addiction
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Intervention groups
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Intervention group1: In this group, granisetron at a dose of 3 mg equivalent to 3 ml is injected slow intravenously immediately before spinal anesthesia. Intervention group 2 : In this group, ondansetron in a dose of 4 mg in a volume of 3 ml is injected slowly into intravenous patients immediately before spinal anesthesia. Control group: In this group, 3 ml normal saline is injected slow intravenously immediately before spinal anesthesia.
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Main outcome variables
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Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate