Use of Vasopressors in Hypotension Associated With Spinal Anaesthesia in Caesarean Sections

Bakirkoy Dr. Sadi Konuk Research and Training Hospital70 enrolled

Overview

This study was designed as a prospective randomised study. In this study, the researchers planned to evaluate the effect of intravenous vasopressor agents administered to patients undergoing caesarean section under spinal anaesthesia on the incidence of hypotension. Our other aim was to evaluate perioperative haemodynamic data, maternal side effects and neonatal outcomes.

Caesarean section is a significant procedure in obstetric patients and constitutes the vast majority of such operations. Regional anaesthesia is currently used in these patients, predominantly spinal anaesthesia. Considering the maternal and foetal side effects of hypotension associated with spinal anaesthesia, it is necessary to prevent this. Vasopressors such as phenylephrine, ephedrine and norepinephrine are used for this purpose. To this end, the researchers aimed to evaluate the effect of ephedrine or norepinephrine administered in patients undergoing caesarean section under spinal anaesthesia on the incidence of hypotension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Caesarean Section

Interventions

Patients who received 10 mg of ephedrine intravenously after spinal anaesthesia during caesarean sectionPROCEDURE

To prevent intraoperative hypotension, researchers administered 10 mg intravenous ephedrine to a group of patients after spinal anaesthesia.

Patients who received 8 mcg intravenous norepinephrine after spinal anaesthesia during caesarean sectionPROCEDURE

To prevent intraoperative hypotension, researchers administered 8 mcg intravenous norepinephrine to a group of patients after spinal anaesthesia.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant patients aged 18-45 * Pregnant patients with ASA 2 * Healthy pregnant women with a gestational age of 37-41 weeks Exclusion Criteria: * Pregnant patients with \>ASA III Emergency cases multiple pregnancy preterm pregnancy pregnant women with foetal anomaly and placental anomaly those diagnosed with pre-eclampsia and eclampsia those with maternal cardiovascular and cerebrovascular disease body mass index \> 40 kg/m² pregnant women with contraindications for spinal anaesthesia and who do not consent to the study

Locations (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

intraoperative hypotension

Our primary objective was to compare the incidence of intraoperative hypotension. In the study, hypotension was defined as a blood pressure level lower than 80% of the baseline systolic arterial pressure (SAP). Hypotension was determined in both groups when the systolic arterial pressure was lower than 80% despite the administration of ephedrine or norepinephrine after spinal anaesthesia

Time frame: Intraoperative

Assessment of intraoperative heart rate

Our secondary objective is to assess the intraoperative heart rate. These time intervals were at the start of surgery, after the patient was placed in the sitting position, after spinal anaesthesia was administered, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and 15 minutes after spinal anaesthesia, 1 minute after delivery, 10 minutes, 20 minutes, 30 minutes, and 40 minutes after delivery, and at the end of surgery.

Time frame: intraoperative

Data from ClinicalTrials.gov

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