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

Primary Purpose

Anesthesia; Adverse Effect, Cesarean Section Complications

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia; Adverse Effect

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo university, Kasr Alainy hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

3 mcg grup

4 mcg group

5 mcg group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome
measuring HCO3 from umbilical cord blood gases analysis

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2022
Last Updated
August 16, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05368415
Brief Title
Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
Official Title
Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Cesarean Section Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 mcg grup
Arm Type
Active Comparator
Arm Description
this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.
Arm Title
4 mcg group
Arm Type
Active Comparator
Arm Description
this group will receive Norepinephrine bolus of 4 mcg for management of hypotension
Arm Title
5 mcg group
Arm Type
Active Comparator
Arm Description
this group will receive Norepinephrine bolus of 5 mcg for management of hypotension
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
levophed
Intervention Description
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
Primary Outcome Measure Information:
Title
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome
Description
measuring HCO3 from umbilical cord blood gases analysis
Time Frame
up to 5 minutes after delivery
Secondary Outcome Measure Information:
Title
Rate of successful management of maternal hypotension
Description
defined as returned of SBP to be > 80% of the baseline reading in the next reading 2 minutes after administration of NE bolus
Time Frame
2 minutes after NE bolus

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Arafa, MD
Organizational Affiliation
Lecturer of anesthesia and surgical ICU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university, Kasr Alainy hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
upon reasonable request
IPD Sharing Time Frame
August 2022
Citations:
PubMed Identifier
32303180
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.
Results Reference
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PubMed Identifier
30935897
Citation
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.
Results Reference
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Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

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