Comparison of the Effect of Phenylephrine Prophylactic Infusion with Placebo Group on Hypertension and Nausea and Vomiting of Pregnant Women During Cesarean Section Under Spinal Anesthesia

Determination of the Effect of Phenylephrine Infusion on Maternal Hemodynamic Changes during Spinal Anesthesia for Cesarean Delivery

A randomized, placebo-controlled, parallel, double-blind clinical trial , 116 samples, phase 3

This study was a double-blind randomized controlled trial that conducted on 116 pregnant women candidate for elective cesarean section by spinal anesthesia in Shahid Akbarabadi hospital (Tehran) in 2019

Inclusion criteria: pregnant woman 18-45 years, candidate for cesarean section by spinal anesthesia, ASA1 & 2 and elective cesarean section. exclusion criteria: a history of allergy to phenylephrine, BMI>30 Kg/M2, hypertension (>140/90 mmHg), contraindication for spinal anesthesia, severe cardiovascular disease, prematurity, emergency cesarean section and inadequate analgesia after spinal anesthesia.

In the intervention group, 35 µg / kg phenylephrine was injected. Spinal anesthesia was performed with 12 mg bupivacaine 0.6% in a sitting position in the L3-L4 or L5-L4 space using the G25 spinal needle. After anesthesia, the patient was placed in the retina position with a slight displacement of the uterus to prevent uterine pressure on the aorta and vena cows. By the time of the baby's birth, blood pressure is measured every two minutes.

systolic blood pressure, diastolic blood pressure, heart rate

A quadratic permutation block method was used. Subjects in blocks 1, 3 and 5 entered into the control group and subjects in blocks 2, 4 and 6 entered into the intervention group and simple randomized table was used to select blocks. The random assignment sheet will be used by trained personnel to assign patients to study groups (Concealment).

The placebo was similar to the drug regarding shape of syringe, color, and volume and the researcher and patient were not aware of the type of injection or placebo. The outcome assessor did not know the types of the patient's intervention and only had the patient's specific code.

The data will be available one month after the responsible person's approval

The access period will start from 2019 to 2021

Data will be available to researchers working in the university.

Just for performing research

Refer to the responsible person for accessing the data

The data will be available one month after the responsible person's approval