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

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ClinicalTrials.gov Identifier: NCT03712111
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
In this study the investigators will compare the efficacy and side effects of two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Spinal Anesthetic Toxicity Drug: Norepinephrine 6 mcg Drug: Norepinephrine 10 mcg Drug: Bupivacaine Hydrochloride Drug: Norepinephrine infusion Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Norepinephrine for Management of Post-spinal Hypotension During Cesarean Delivery: a Randomized, Controlled, Comparison of Two Bolus Doses
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : June 25, 2019
Estimated Study Completion Date : July 1, 2019


Arm Intervention/treatment
Experimental: Norepinephrine 6 mcg
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
Drug: Norepinephrine 6 mcg
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
Other Name: Levophed

Drug: Bupivacaine Hydrochloride
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg
Other Name: Marcaine

Drug: Norepinephrine infusion
Prophylactic norepinephrine infusion will be started after subarachnoid block
Other Name: Levophed

Active Comparator: Norepinephrine 10 mcg
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
Drug: Norepinephrine 10 mcg
An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
Other Name: Levophed

Drug: Bupivacaine Hydrochloride
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg
Other Name: Marcaine

Drug: Norepinephrine infusion
Prophylactic norepinephrine infusion will be started after subarachnoid block
Other Name: Levophed




Primary Outcome Measures :
  1. Rate of successful management of maternal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    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 :
  1. Rate of successful management of severe maternal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    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)

  2. incidence of reactive hypertension [ Time Frame: 30 minutes after spinal anesthesia ]
    number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus)

  3. systolic blood pressure [ Time Frame: 90 minutes after spinal anesthesia ]
    systolic blood pressure measured in mmHg

  4. heart rate [ Time Frame: 90 minutes after spinal block ]
    number of heart beats per minute

  5. Apgar score for evaluation of the activity of the fetus [ Time Frame: 10 minutes ]
    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

  6. Umbilical blood acidity [ Time Frame: 10 minutes after delivery ]
    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.

  7. The frequency of vomiting [ Time Frame: 90 minutes after spinal anesthesia ]
    The number of patients with vomiting



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712111


Contacts
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Contact: Sarah Amin, Lecturer +201227476617 sarahamin_22@hotmail.com

Locations
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Egypt
Ahmed Mohamed Hasanin Recruiting
Cairo, Egypt, 11432
Contact: Ahmed M Hasanin    1095076954      
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Hasanin, Professor Assistant professor of anesthesia

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Responsible Party: Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
ClinicalTrials.gov Identifier: NCT03712111     History of Changes
Other Study ID Numbers: N-71-2018
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents