Vasopressor Prophylaxis After Spinal Anesthesia

Phase 4

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: Norepinephrine 0.05 mcg /Kg/min; Drug: Norepinephrine 0.1 mcg /Kg/min; Drug: Norepinephrine 0.15 mcg /Kg/min; Drug: Bupivacaine

• Registration Number: NCT03234816
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-31
• Study Start: 2017-08-02
• Primary Completion: 2018-11-02
• Study Completion: 2018-12-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• full term singleton pregnant women
• Scheduled for elective Cesarean Delivery
• Aged between 18 and 40 years

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
- 0.05 mcg /Kg/min group	Norepinephrine 0.05 mcg /Kg/min	will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
- 0.1 mcg /Kg/min group	Norepinephrine 0.1 mcg /Kg/min	will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
- 0.15 mcg /Kg/min group	Norepinephrine 0.15 mcg /Kg/min	will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
- 0.1 mcg /Kg/min group	Bupivacaine	will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
- 0.05 mcg /Kg/min group	Bupivacaine	will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
- 0.15 mcg /Kg/min group	Bupivacaine	will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Primary Outcome Measures

Name	Time	Method
incidence of postspinal hypotension	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

Name	Time	Method
heart rate	90 minutes after spinal anesthesia	heart rate after spinal anesthesia measured in beat per minute
vomiting	120 minutes after spinal anesthesia	incidence of vomiting after spinal anesthesia
nausea	120 minutes after spinal anesthesia	incidence of nausea after spinal anesthesia
ephedrine consumption	60 minutes after spinal anesthesia	total amount of ephedrine consumed after spinal anesthesia
Atropine consumption	60 minutes after spinal anesthesia	total amount of atropine consumed after spinal anesthesia
APGAR score	10 minutes after delivery	APGAR score of the delivered fetus
incidence of severe postspinal hypotension	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
arterial blood pressure	90 minutes after spinal anesthesia	arterial blood pressure after spinal anesthesia measured in mmHg

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt