The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
NCT Number: NCT03507387
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.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Xuzhou, Jiangsu, 221000, China
Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
Other names: Metasympatol
1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
Other names: Physiological saline
All patients will receive spinal anesthesia with bupivacaine.
Other names: Marcaine
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
detected by a blood gase analyzer
Time frame: after the baby is delivered
Umbilical artery pH value<7.20
Time frame: intraoperative
decrease of systolic blood pressure>20% baseline values
Time frame: intraoperative
increase of systolic blood pressure>20% baseline values
Time frame: intraoperative
heart rate <50 bpm
Time frame: intraoperative
observed by the anesthesiologist
Xuzhou Medical University
Other
Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04083768
Elective Cesarean Section, Spinal Anesthesia
Xuzhou, Jiangsu, China
View Trial DetailsNCT07657663
Birth Beliefs, Childbirth Education
Burdur, Bucak, Turkey (Türkiye)
View Trial DetailsNCT07406373
Cesarean Section, Elective Cesarean Section
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07276594
Anxiety Disorders, Elective Cesarean Section
Adıyaman, Adıyaman Province, Turkey (Türkiye)
View Trial Details