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Norepinephrine Versus Phenylephrine 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: NCT03248791
Recruitment Status : Unknown
Verified January 2018 by Ahmed Hasanin, Cairo University.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively 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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, 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 Trial
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : March 10, 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
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 infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
Drug: Norepinephrine
Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
Other Name: noradrenaline

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

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

  6. APGAR score [ Time Frame: 10 minutes after delivery ]
    APGAR score of the fetus

  7. 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



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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-ecpamsia
  • eclampsia
  • bleeding
  • cardiac dysfuction

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): NCT03248791


Contacts
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Contact: Ahmed Hasanin, Professor +201095076954 ahmedmohamedhasanin@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: ahmed Shash, Professor    +201001033999      
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: NCT03248791    
Other Study ID Numbers: N-86-2017
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 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