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Norepinephrine Infusion Different Doses in Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182088
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: norepinephrine infusion (0.025 mcg/Kg/min) Drug: norepinephrine infusion (0.050 mcg/Kg/min) Drug: norepinephrine infusion (0.075 mcg/Kg/min) Drug: Bupivacaine Phase 4

Detailed Description:

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : December 25, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.025 mcg /Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).
Drug: norepinephrine infusion (0.025 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
Other Name: noradrenaline infusion

Drug: Bupivacaine
The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Other Names:
  • spinal anesthesia
  • Heavy marcaine

Experimental: 0.050 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).
Drug: norepinephrine infusion (0.050 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
Other Name: noradrenaline infusion

Drug: Bupivacaine
The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Other Names:
  • spinal anesthesia
  • Heavy marcaine

Experimental: 0.075 mcg/Kg/min group
The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)
Drug: norepinephrine infusion (0.075 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
Other Name: noradrenaline infusion

Drug: Bupivacaine
The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Other Names:
  • spinal anesthesia
  • Heavy marcaine




Primary Outcome Measures :
  1. postspinal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group


Secondary Outcome Measures :
  1. severe postspinal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

  2. Post-delivery hypotension [ Time Frame: 10 minutes after delivery ]
    number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)

  3. systolic blood pressure [ Time Frame: 60 minutes after spinal block ]
    systolic blood pressure measured in mmHg

  4. diastolic blood pressure [ Time Frame: 60 minutes after spinal block ]
    diastolic blood pressure measured in mmHg

  5. heart rate [ Time Frame: 60 minutes after spinal block ]
    heart rate measured in beats per minute

  6. intraoperative hypertension [ Time Frame: 60 minutes after spinal block ]
    number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group

  7. incidence of nausea and vomiting [ Time Frame: 60 minutes after spinal block ]
    number of patients who develop nausea and vomiting divided by the total number of patients in the group

  8. ephedrine consumption [ Time Frame: 60 minutes after spinal block ]
    total amount of ephedrine consumed during the operation (measured in milligrams)

  9. Atropine consumption [ Time Frame: 60 minutes after spinal block ]
    total amount of atropine consumed during the operation (measured in milligrams)

  10. APGAR score [ Time Frame: 1 minute after delivery ]
    APGAR score for detection of the well being of the fetus

  11. APGAR score [ Time Frame: 10 minutes after delivery ]
    APGAR score for detection of the well being of the fetus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • full term
  • singleton
  • pregnant women
  • scheduled for elective cesarean delivery

Exclusion Criteria:

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • baseline systolic blood pressure (SBP) < 100 mmHg
  • body mass index > 35 will be excluded from the study.

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): NCT03182088


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department
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Responsible Party: Ahmed Hasanin, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03182088    
Other Study ID Numbers: N-49-2017
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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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