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NCT Number: NCT07384455

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

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.

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Key information

Conditions

Caesarean Section Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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 section

Procedure

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

Primary outcomes

  1. intraoperative hypotension

    Time frame: Intraoperative

    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

  2. Assessment of intraoperative heart rate

    Time frame: intraoperative

    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.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparıson of the effectıveness of ephedrıne and norepınephrıne ın the Treatment of hypotensıon developıng ın spınal anaesthesıa durıng Caesarean sectıon surgerıes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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