Study Results
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Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2017-08-02
2018-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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- 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
Norepinephrine 0.05 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
- 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
Norepinephrine 0.1 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
- 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
Norepinephrine 0.15 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
Interventions
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Norepinephrine 0.05 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Norepinephrine 0.1 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Norepinephrine 0.15 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
Bupivacaine
10 mg Bupivacaine intra-thecal for spinal anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective Cesarean Delivery
* Aged between 18 and 40 years
Exclusion Criteria
* Hypertensive disorders of pregnancy,
* Peripartum bleeding
* Baseline systolic blood pressure (SBP) \< 100 mmHg
* Body mass index \> 35
18 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Hasanin
Principal investigator, Lecturer of anesthesia and critical care medicine
Principal Investigators
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Ahmed Mukhtar, Professor
Role: STUDY_DIRECTOR
Head of research committee section in anesthesia department
Locations
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Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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N_66_2017
Identifier Type: -
Identifier Source: org_study_id
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