Norepinephrine Infusion Different Doses in Cesarean Delivery

Phase 4

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: norepinephrine infusion (0.025 mcg/Kg/min); Drug: norepinephrine infusion (0.050 mcg/Kg/min); Drug: norepinephrine infusion (0.075 mcg/Kg/min); Drug: Bupivacaine

• Registration Number: NCT03182088
• Lead Sponsor: Cairo University

Brief Summary

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia 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 agonist activity in addition to a weak β adrenergic agonist 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, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared 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: 2017-06-07
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-06-15
• Primary Completion: 2017-12-25
• Study Completion: 2017-12-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 284

Inclusion Criteria

• full term
• singleton
• pregnant women
• scheduled for elective cesarean delivery

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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 will be excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.025 mcg /Kg/min group	norepinephrine infusion (0.025 mcg/Kg/min)	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).
0.050 mcg/Kg/min group	norepinephrine infusion (0.050 mcg/Kg/min)	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).
0.075 mcg/Kg/min group	norepinephrine infusion (0.075 mcg/Kg/min)	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)
0.025 mcg /Kg/min group	Bupivacaine	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).
0.050 mcg/Kg/min group	Bupivacaine	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).
0.075 mcg/Kg/min group	Bupivacaine	The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)

Primary Outcome Measures

Name	Time	Method
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
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
Atropine consumption	60 minutes after spinal block	total amount of atropine consumed during the operation (measured in milligrams)
intraoperative hypertension	60 minutes after spinal block	number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group
ephedrine consumption	60 minutes after spinal block	total amount of ephedrine consumed during the operation (measured in milligrams)
heart rate	60 minutes after spinal block	heart rate measured in beats per minute
incidence of nausea and vomiting	60 minutes after spinal block	number of patients who develop nausea and vomiting divided by the total number of patients in the group
Post-delivery hypotension	10 minutes after delivery	number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)
systolic blood pressure	60 minutes after spinal block	systolic blood pressure measured in mmHg
diastolic blood pressure	60 minutes after spinal block	diastolic blood pressure measured in mmHg
APGAR score	10 minutes after delivery	APGAR score for detection of the well being of the fetus

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt