Cesarean Section, Hypotension, Norepinephrine
Conditions
Keywords
Norepinephrine, Spinal anesthesia, Hypotension, Cesarean section
Brief summary
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
DRUGNorepinephrine (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.
DRUGNorepinephrine (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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of post-spinal hypotension | During the first hour after the subarachnoid block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood pressure (Systolic, diastolic, and mean) | During the first hour after the subarachnoid block | — |
| Heart rate | During the first hour after the subarachnoid block | — |
| Doses of atropine and ephedrine | Intraoperative | — |
| Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score | 1, 5, and 10 minutes after delivery | Ranges from 0 (the worst score) to 10 (the best score) |
Countries
Egypt
Contacts
Primary ContactZakaria A. Zakaria
Outcome results
None listed