drugset / Trial / NCT03507387

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

NCT03507387

Completed 99 enrolled Xuzhou Medical University
RandomizedParallel-groupTriple-blindPrevention

Summary

Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

Timeline

Start
2018-04-01
Primary completion
2018-08-31
Completion
2018-08-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 100 ug Intramuscular
Subject Phenylephrine Small molecule 5 mg Intramuscular
Background Bupivacaine Other / unclassified Intrathecal

Indications

No indication recorded.