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

NCT05368415 | Completed Phase 4

• 1 other identifier: Levo bolus in CS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of successful management of maternal hypotension

  2 minutes after NE bolus

Study Arms (3)

3 mcg grup

ACTIVE COMPARATOR

this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.

Drug: Norepinephrine

4 mcg group

ACTIVE COMPARATOR

this group will receive Norepinephrine bolus of 4 mcg for management of hypotension

Drug: Norepinephrine

5 mcg group

ACTIVE COMPARATOR

this group will receive Norepinephrine bolus of 5 mcg for management of hypotension

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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

Also known as: levophed

3 mcg grup; 4 mcg group; 5 mcg group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant female with preeclampsia
• age 18-40

You may not qualify if:

• age less than 18
• age above 40
• patient refusal of spinal anesthesia
• patient with eclampsia
• patient allergy to anesthesia drugs or to NE

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university, Kasr Alainy hospital

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 32303180 BACKGROUND

• 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.

  PMID: 30935897 BACKGROUND

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mohamed S Arafa, MD

  Lecturer of anesthesia and surgical ICU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: May 15, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 15, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: August 2022

Locations

EG (1)