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

Phase 4

Completed

• Conditions: Anesthesia; Adverse Effect; Cesarean Section Complications
• Interventions: Drug: Norepinephrine

• Registration Number: NCT05368415
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-10
• Study Start: 2022-05-15
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 mcg grup	Norepinephrine	this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.
4 mcg group	Norepinephrine	this group will receive Norepinephrine bolus of 4 mcg for management of hypotension
5 mcg group	Norepinephrine	this group will receive Norepinephrine bolus of 5 mcg for management of hypotension

Primary Outcome Measures

Name	Time	Method
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome	up to 5 minutes after delivery	measuring HCO3 from umbilical cord blood gases analysis

Secondary Outcome Measures

Name	Time	Method
Rate of successful management of maternal hypotension	2 minutes after NE bolus	defined as returned of SBP to be \> 80% of the baseline reading in the next reading 2 minutes after administration of NE bolus

Trial Locations

Locations (1)

Cairo university, Kasr Alainy hospital; 🇪🇬 Cairo, Egypt