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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07384455
Enrollment
70
Registered
2026-02-03
Start date
2021-01-03
Completion date
2021-08-31
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section

Keywords

spinal anesthesia, Hypotension, Norepinephrine

Brief summary

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.

Detailed 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.

Interventions

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

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

PROCEDUREPatients who received 8 mcg intravenous norepinephrine after spinal anaesthesia during caesarean section

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

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Prospective randomize study

Intervention model description

Prospective randomize study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intraoperative hypotensionIntraoperativeOur 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
Assessment of intraoperative heart rateintraoperativeOur 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026