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Norepinephrine Versus Phenylephrine Continuous Variable Infusion 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: NCT03328533
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Spinal Anesthesia Drug: Phenylephrine Drug: Norepinephrine Drug: Bupivacaine Phase 4

Detailed Description:
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 5, 2018


Arm Intervention/treatment
Active Comparator: Phenylephrine
Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
Drug: Phenylephrine
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.

Drug: Bupivacaine
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
Other Name: Marcaine

Experimental: Norepinephrine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
Drug: Norepinephrine
Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
Other Name: Levophed

Drug: Bupivacaine
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
Other Name: Marcaine




Primary Outcome Measures :
  1. Incidence of post-spinal anesthesia hypotension. [ Time Frame: 30 minutes after spinal anesthesia ]
    Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading


Secondary Outcome Measures :
  1. Incidence of severe post-spinal anesthesia hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading

  2. Incidence of severe delivery hypotension [ Time Frame: 10 minutes after delivery ]
    Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading

  3. Systolic blood pressure [ Time Frame: 2 hours after subarachnoid block ]
    Systolic blood pressure measured in mmHg

  4. Heart rate [ Time Frame: 2 hours after subarachnoid block ]
    number of heart beats per minute

  5. APGAR score for assessment of the general state of the fetus [ Time Frame: 10 minutes after delivery ]
    APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score

  6. Incidence of reactive hypertension [ Time Frame: 2 hours after spinal anesthesia ]
    Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading

  7. Umbilical arterial potential hydrogen (PH) [ Time Frame: 10 minutes after delivery ]
    PH in the blood sample obtained from umbilical artery scaled from 1 to 14

  8. Umbilical arterial Partial pressure of Carbon dioxide [ Time Frame: 10 minutes after delivery ]
    in the blood sample obtained from umbilical artery measured in mmHg

  9. incidence of nausea [ Time Frame: 2 hours ]
    The percentage of patients with nausea

  10. Incidence of vomiting [ Time Frame: 2 hours ]
    The percentage of patients with nausea

  11. Total phenylephrine consumption [ Time Frame: 2 hours ]
    the total dose of phenylephrine consumed during the operation

  12. Total norepinephrine consumption [ Time Frame: 2 hours ]
    the total dose of norepinephrine consumed during the operation

  13. Total ephedrine consumption [ Time Frame: 2 hours ]
    the total dose of ephedrine consumed during the operation



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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
  • Pregnant women
  • Scheduled for cesarean section

Exclusion Criteria:

  • Pre-eclampsia
  • Eclampsia
  • Bleeding
  • Cardiac dysfunction

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): NCT03328533


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed M 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: NCT03328533    
Other Study ID Numbers: N-82-2017
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 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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Phenylephrine
Oxymetazoline
Norepinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents