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Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery

Primary Purpose

Cesarean Section Complications, Spinal Anesthetic Toxicity

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine 6 mcg
Norepinephrine 10 mcg
Norepinephrine infusion
Bupivacaine hydrochloride
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section Complications

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women
  • Scheduled for cesarean delivery

Exclusion Criteria:

  • Patients with severe cardiac dysfunction
  • Patients with low blood pressure
  • Patients with ante-partum bleeding

Sites / Locations

  • Ahmed Mohamed Hasanin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norepinephrine 6 mcg

Norepinephrine 10 mcg

Arm Description

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.

Outcomes

Primary Outcome Measures

Rate of successful management of maternal hypotension
number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).

Secondary Outcome Measures

Rate of successful management of severe maternal hypotension.
number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
Incidence of reactive hypertension
number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).
Systolic blood pressure.
Systolic blood pressure measured in mmHg.
Heart rate
Number of heart beats per minute.
Apgar score for evaluation of the activity of the fetus
the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10.
Umbilical blood acidity
the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.
The frequency of vomiting.
The number of patients with vomiting.
Incidence of bradycardia
number of patients with bradycardia (defined as heart rate less than 55 beat per minute after administration of norepinephrine bolus).

Full Information

First Posted
January 2, 2019
Last Updated
September 22, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03792906
Brief Title
Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery
Official Title
Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.
Detailed Description
Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed . The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output . Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension. No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Spinal Anesthetic Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine 6 mcg
Arm Type
Experimental
Arm Description
Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion
Arm Title
Norepinephrine 10 mcg
Arm Type
Active Comparator
Arm Description
Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine 6 mcg
Other Intervention Name(s)
Levophed
Intervention Description
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine 10 mcg
Other Intervention Name(s)
Levophed
Intervention Description
An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine infusion
Other Intervention Name(s)
Levophed
Intervention Description
Prophylactic norepinephrine infusion will be started after subarachnoid block.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrochloride
Other Intervention Name(s)
marcaine
Intervention Description
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.
Primary Outcome Measure Information:
Title
Rate of successful management of maternal hypotension
Description
number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
Time Frame
30 minutes after spinal anesthesia
Secondary Outcome Measure Information:
Title
Rate of successful management of severe maternal hypotension.
Description
number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
Time Frame
30 minutes after spinal anesthesia
Title
Incidence of reactive hypertension
Description
number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).
Time Frame
30 minutes after spinal anesthesia
Title
Systolic blood pressure.
Description
Systolic blood pressure measured in mmHg.
Time Frame
2 hours after subarachnoid block
Title
Heart rate
Description
Number of heart beats per minute.
Time Frame
2 hours after subarachnoid block
Title
Apgar score for evaluation of the activity of the fetus
Description
the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10.
Time Frame
10 minutes
Title
Umbilical blood acidity
Description
the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.
Time Frame
10 minutes after delivery
Title
The frequency of vomiting.
Description
The number of patients with vomiting.
Time Frame
2 hours after subarachnoid block
Title
Incidence of bradycardia
Description
number of patients with bradycardia (defined as heart rate less than 55 beat per minute after administration of norepinephrine bolus).
Time Frame
2 hours after subarachnoid block

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women Scheduled for cesarean delivery Exclusion Criteria: Patients with severe cardiac dysfunction Patients with low blood pressure Patients with ante-partum bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Hasanin, Professor
Organizational Affiliation
Assistant professor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Mohamed Hasanin
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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
derived

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Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery

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