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

NCT07384455 | Completed

• 1 other identifier: 2021-24695
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Caesarean Section

Keywords

spinal anesthesia; Hypotension; Norepinephrine

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  intraoperative

Study Arms (2)

10 mg ephedrine intravenously after spinal anaesthesia

EXPERIMENTAL

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

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

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

Interventions

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.

8 mcg of norepinephrine intravenously following spinal anaesthesia

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.

10 mg ephedrine intravenously after spinal anaesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients aged 18-45
• Pregnant patients with ASA 2
• Healthy pregnant women with a gestational age of 37-41 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Mushambi MC, Kinsella SM, Popat M, Swales H, Ramaswamy KK, Winton AL, Quinn AC; Obstetric Anaesthetists' Association; Difficult Airway Society. Obstetric Anaesthetists' Association and Difficult Airway Society guidelines for the management of difficult and failed tracheal intubation in obstetrics. Anaesthesia. 2015 Nov;70(11):1286-306. doi: 10.1111/anae.13260.

  PMID: 26449292 RESULT

• Singh PM, Singh NP, Reschke M, Ngan Kee WD, Palanisamy A, Monks DT. Vasopressor drugs for the prevention and treatment of hypotension during neuraxial anaesthesia for Caesarean delivery: a Bayesian network meta-analysis of fetal and maternal outcomes. Br J Anaesth. 2020 Mar;124(3):e95-e107. doi: 10.1016/j.bja.2019.09.045. Epub 2019 Dec 4.

  PMID: 31810562 RESULT

• Massoth C, Topel L, Wenk M. Hypotension after spinal anesthesia for cesarean section: how to approach the iatrogenic sympathectomy. Curr Opin Anaesthesiol. 2020 Jun;33(3):291-298. doi: 10.1097/ACO.0000000000000848.

  PMID: 32371631 RESULT

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

  PMID: 29090733 RESULT

• Allen TK, George RB, White WD, Muir HA, Habib AS. A double-blind, placebo-controlled trial of four fixed rate infusion regimens of phenylephrine for hemodynamic support during spinal anesthesia for cesarean delivery. Anesth Analg. 2010 Nov;111(5):1221-9. doi: 10.1213/ANE.0b013e3181e1db21. Epub 2010 May 21.

  PMID: 20495139 RESULT

• Park HS, Choi WJ. Use of vasopressors to manage spinal anesthesia-induced hypotension during cesarean delivery. Anesth Pain Med (Seoul). 2024 Apr;19(2):85-93. doi: 10.17085/apm.24037. Epub 2024 Apr 30.

  PMID: 38725163 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Prospective randomize study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, co-investigator

Model Details: Prospective randomize study

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 3, 2026
• Study Start: January 3, 2021
• Primary Completion: August 3, 2021
• Study Completion: August 31, 2021
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

TU (1)