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

NCT ID: NCT06102382

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Cesarean Section Hypotension Norepinephrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Norepinephrine (0.1)

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.

Group Type EXPERIMENTAL

Norepinephrine (0.1)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Norepinephrine (0.075)

Intervention Type 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.

Interventions

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Norepinephrine (0.1)

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.

Intervention Type DRUG

Norepinephrine (0.075)

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Zakaria Ahmed Zakaria

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Woman Health Hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Zakaria A. Zakaria

Role: CONTACT

+201150637566

Facility Contacts

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Zakaria Ah. Zakaria

Role: primary

Hany M. Osman, M.D.

Role: backup

Other Identifiers

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Noradrenaline in CS under SA

Identifier Type: -

Identifier Source: org_study_id

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