Mie elective Caesarean section Anesthesia trial (MCA trial)

JRCT ID: jRCTs041230178

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hypotension
• Date of first enrollment: 12/04/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): In the study treatment group, administration of phenylephrine hydrochloride (0.5 mcg/kg/min) is initiated prior to spinal anesthesia. The administration of phenylephrine hydrochloride prior to spinal anesthesia will be started after at least 5 minutes have elapsed since the start of the phenylephrine hydrochloride administration.

Outcome(s)

• Primary Outcome: Maternal blood pressure variability from spinal anesthesia to delivery of the infant (evaluation period)

Secondary Outcome

Group differences in maternal and neonatal background maternal-related information, age, delivery week, complications, height, pre-pregnancy weight, weight at delivery, number of births, neonatal-related information, sex, APGAR Score, 1 min value 5 min value, height, weight

Blood pressure related parameters
Number of occurrence of hypotension measured by brachial manchette, maximum systolic blood pressure, minimum systolic blood pressure, maximum diastolic blood pressure, minimum systolic blood pressure, maternal blood pressure changes during the observation period
maximum systolic blood pressure manus minimum systolic blood pressure, maximum diastolic blood pressure mainus minimum diastolic blood pressure

Occurrence of hypotension measured by CLEARSIGHT, maximum systolic blood pressure, minimum systolic blood pressure, maximum diastolic blood pressure, minimum systolic blood pressure, course of maternal cardiac output, and changes in maternal blood pressure during the observation period
maximum systolic blood pressure mainus minimum systolic blood pressure
maximum diastolic blood pressure mainus minimum diastolic blood pressure

Neonatal effects: umbilical cord blood gas analysis, pH, Base Ecess, pCO2, pO2, neonatal blood glucose,after birth,
Neonatal blood glucose,from blood tests in the NICU after birth, frequency of neonatal respiratory support needs,for respiratory support required after postnatal resuscitation, NICU admission, and NICU admission.
initial blood test findings after admission to the NICU, blood gas analysis,

Placental weight
Total dose of phenylephrine hydrochloride, mg; from the start of lumbar anesthesia to the delivery of the infant, and from the start of lumbar anesthesia to the end of surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Age 18 years or older
2) Elective cesarean section after 37 weeks of pregnancy
3) Singleton pregnancy
4) Written consent has been obtained from the patient

Exclude criteria

Patients with hypertension systolic blood pressure over140 mmHg or diastolic blood pressure over90 mmHg) at the time of registration
Patients with cardiac, vascular, renal, or coagulation disorders
Patients with pregnancy-related complications, hypertension, gestational hypertension, chronic kidney disease, etc.
Those with either amniotic fluid abnormalities or fetal growth retardation
Those with fetal malformations that affect umbilical artery blood gas analysis and neonatal respiratory support after birth
Those with drug allergy to phenylephrine hydrochloride
Those who are judged by the principal investigator/associate investigator to be inappropriate as subjects for this clinical trial

Related Information

• Primary Sponsor: Magawa Shoichi
• Source(s) of Monetary Support: Mie university hospital clinical research scholarship