Hypotension Clinical Trial
Official title:
Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine
to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be
conducted in a randomized double-blinded fashion. This dose-response study will be conducted
as per the up-down sequential allocation method, modified by the Narayana rule, designed to
cluster the results around the ED95.
Blood pressure will be monitored every minute from intrathecal injection to the delivery of
the child. Phenylephrine will be administered every time the blood pressure is equal to or
lower than the control value.Hypotension will be defined as a SBP less than 80 % of the
baseline value, in which case the treatment will be a failure. Hypertension will be defined
as a SBP more than 120 % of baseline value. If a patient presents hypertension for two
consecutive measurements, the case will be considered a drop out.An adequate response will
be defined as the absence of hypotension or nausea/vomiting during the period from induction
of spinal anesthesia to uterine incision prior to fetal delivery.
The results of this study will define the minimum effective dose of phenylephrine to prevent
post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section,
thus optimizing the safety profile with respect to maternal and fetal side effects of this
vasopressor.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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