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NCT Number: NCT06102382

The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

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Key information

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Woman Health Hospital

Asyut, Egypt

Location status: Recruiting

Location contact

Hany M. Osman, M.D.

CONTACT

[email protected]

Zakaria Ah. Zakaria

CONTACT

[email protected]

About this study

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.

Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.

Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.

The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women scheduled for cesarean section under spinal anesthesia
  • Gestational age of at least 37 weeks

Exclusion criteria

  • Patient refusal
  • Contraindications of spinal anesthesia
  • Allergy to the study drug
  • Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
  • patients with cardiac morbidities
  • Hypertensive disorders of pregnancy.
  • Prepartum hemorrhage

Treatment and study plan

Norepinephrine (0.1)

Drug

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.

Norepinephrine (0.075)

Drug

An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Primary outcomes

  1. The frequency of post-spinal hypotension

    Time frame: During the first hour after the subarachnoid block

Secondary outcomes

  1. Arterial blood pressure (Systolic, diastolic, and mean)

    Time frame: During the first hour after the subarachnoid block

  2. Heart rate

    Time frame: During the first hour after the subarachnoid block

  3. Doses of atropine and ephedrine

    Time frame: Intraoperative

  4. Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score

    Time frame: 1, 5, and 10 minutes after delivery

    Ranges from 0 (the worst score) to 10 (the best score)

Study contacts

Contact information is provided by the study sponsor or research team.

Zakaria A. Zakaria

CONTACT

[email protected]

+201150637566

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2023
Registry last updated
Aug 29, 2025

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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