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

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Caesarean Section

Treatments: Procedure: Patients who received 8 mcg intravenous norepinephrine after spinal anaesthesia during caesarean section; Procedure: Patients who received 10 mg of ephedrine intravenously after spinal anaesthesia during caesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT07384455

2021-24695

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

10 mg ephedrine intravenously after spinal anaesthesia

Experimental group

Description:

Group 1: Group administered 10 mg ephedrine intravenously after spinal anaesthesia

Treatment:

Procedure: Patients who received 10 mg of ephedrine intravenously after spinal anaesthesia during caesarean section

8 mcg of norepinephrine intravenously following spinal anaesthesia

Experimental group

Description:

Group 2: The group administered 8 mcg of norepinephrine intravenously following spinal anaesthesia

Treatment:

Procedure: Patients who received 8 mcg intravenous norepinephrine after spinal anaesthesia during caesarean section