The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Norepinephrine (0.1), Norepinephrine (0.075).
- Who it may be relevant to
- Registry conditions: Cesarean Section, Hypotension, Norepinephrine. Basic parameters: 19 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
Detailed description
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- The frequency of post-spinal hypotension [Time frame: During the first hour after the subarachnoid block]
Secondary outcome measures (4)
- Arterial blood pressure (Systolic, diastolic, and mean) [Time frame: During the first hour after the subarachnoid block]
- Heart rate [Time frame: During the first hour after the subarachnoid block]
- Doses of atropine and ephedrine [Time frame: Intraoperative]
- Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score [Time frame: 1, 5, and 10 minutes after delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut University Woman Health Hospital — Asyut
Identifiers
NCT: NCT06102382 · Noradrenaline in CS under SA