Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

Study Overview
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Brief Summary
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Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers . The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.

Official Title
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Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

Conditions
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Anesthesia; Adverse Effect, Cesarean Section Complications

Intervention / Treatment
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* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant female with preeclampsia age 18-40 Exclusion Criteria: age less than 18 age above 40 patient refusal of spinal anesthesia patient with eclampsia patient allergy to anesthesia drugs or to NE

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 mcg grup<br>this group will receive Norepinephrine bolus of 3 mcg for management of hypotension. | Drug: Norepinephrine<br>* mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation<br>* Other names: levophed;|
| Active Comparator: 4 mcg group<br>this group will receive Norepinephrine bolus of 4 mcg for management of hypotension | Drug: Norepinephrine<br>* mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation<br>* Other names: levophed;|
| Active Comparator: 5 mcg group<br>this group will receive Norepinephrine bolus of 5 mcg for management of hypotension | Drug: Norepinephrine<br>* mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation<br>* Other names: levophed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome | measuring HCO3 from umbilical cord blood gases analysis | up to 5 minutes after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful management of maternal hypotension | defined as returned of SBP to be > 80% of the baseline reading in the next reading 2 minutes after administration of NE bolus | 2 minutes after NE bolus |