A Randomized, Assigned, Controlled Trial of Phenylephrine Alone versus Phenylephrine and Pre-Spinal Anesthesia Infusion Load Combination Blood Pressure Maintenance During Spinal Anesthesia in Pregnant Women Undergoing Scheduled Cesarean Section

JRCT ID: jRCTs041240008

Registered date:08/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients requiring cesarean section
• Date of first enrollment: 17/06/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): To compare the UApH of patients undergoing scheduled cesarean section under spinal cord with respect to intraoperative infusion in the group without infusion loading (group N) and the group that loads 500 ml of colloidal infusion from the time of admission to the operating room to the completion of spinal cord replacement (group P).

Outcome(s)

• Primary Outcome: Umbilical artery blood pH (UApH)

Secondary Outcome

1.Clinical examination: umbilical artery and vein blood gas analysis, hemoglobin level (preoperative, day after surgery)
2.Intraoperative data: fluid volume until delivery, phenylephrine dose, ephedrine dose, Apgar score (1 min, 5 min), nausea and vomiting, blood loss (excluding amniotic fluid), urine volume, values obtained from Sterling SV, whether and to what extent the infant needs resuscitation (oxygen, CPAP, tracheal intubation, or more)
3.Postoperative data: presence or absence of NICU admission, indication for NICU admission, ObsQoR-10 on the morning following surgery, urine output by the morning following surgery, values obtained from Sterling SV, presence or absence of maternal postoperative complications and their details

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

1. who are scheduled to have an elective cesarean section performed under spinal cord and who will have the cesarean section after 37 weeks and 0 days of pregnancy
2. Patients with a singleton pregnancy.
3. who are between 18 and 45 years of age at the time of consent
4. who have given consent for this study by signing a consent form in person.

Exclude criteria

1. those with any fetal abnormality, including fetal growth retardation
2. those with abnormal placental position
3. Patients with gestational hypertension
4. with cardiac disease (stenotic valve disease, aortic stenosis, angina pectoris), cerebrovascular disease (moyamoya disease, cerebral aneurysm, cerebral arteriovenous malformation), or Abnormal blood coagulation (PT-INR>1.2 or APTT>50), platelet count less than 100,000/microl
5. Patients with hypothyroidism
6. hypermagnesemia (serum magnesium concentration >2.7 mg/dl)
7. obese patients (BMI >30 before pregnancy)
8. who have undergone uterine surgery (including Cesarean section) more than twice.
9. other patients whom the principal investigator or subinvestigator determines are not appropriate to be included in this study.

Related Information

• Primary Sponsor: Akinaga Chieko