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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368415
• Other study ID #: Levo bolus in CS
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Cesarean Section Complications
• Hypotension
• Pre-Eclampsia

Intervention

Drug:
• Norepinephrine
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation

Locations

Country	Name	City	State
Egypt	Cairo university, Kasr Alainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30. — View Citation

Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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