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Vasopressor Prophylaxis After Spinal Anesthesia

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: NCT03234816
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: Norepinephrine 0.05 mcg /Kg/min Drug: Norepinephrine 0.1 mcg /Kg/min Drug: Norepinephrine 0.15 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 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 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, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: - 0.05 mcg /Kg/min group
will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Drug: Norepinephrine 0.05 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Other Name: noradrenaline infusion

Drug: Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
Other Name: marcaine

Experimental: - 0.1 mcg /Kg/min group
will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Drug: Norepinephrine 0.1 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Other Name: noradrenaline infusion

Drug: Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
Other Name: marcaine

Experimental: - 0.15 mcg /Kg/min group
will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Drug: Norepinephrine 0.15 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Other Name: noradrenaline infusion

Drug: Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
Other Name: marcaine




Primary Outcome Measures :
  1. incidence of 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. heart rate [ Time Frame: 90 minutes after spinal anesthesia ]
    heart rate after spinal anesthesia measured in beat per minute

  2. vomiting [ Time Frame: 120 minutes after spinal anesthesia ]
    incidence of vomiting after spinal anesthesia

  3. nausea [ Time Frame: 120 minutes after spinal anesthesia ]
    incidence of nausea after spinal anesthesia

  4. ephedrine consumption [ Time Frame: 60 minutes after spinal anesthesia ]
    total amount of ephedrine consumed after spinal anesthesia

  5. Atropine consumption [ Time Frame: 60 minutes after spinal anesthesia ]
    total amount of atropine consumed after spinal anesthesia

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

  7. incidence of 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

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



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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
  • Aged between 18 and 40 years

Exclusion Criteria:

  • Cardiac morbidities
  • Hypertensive disorders of pregnancy,
  • Peripartum bleeding
  • Baseline systolic blood pressure (SBP) < 100 mmHg
  • Body mass index > 35

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): NCT03234816


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, Principal investigator, Lecturer of anesthesia and critical care medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03234816    
Other Study ID Numbers: N_66_2017
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
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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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