Clinical trial NCT03182088: Norepinephrine Infusion Different Doses in Cesarean Delivery
Official title: Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: severe postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: Post-delivery hypotension
timeFrame: 10 minutes after delivery
measure: systolic blood pressure
timeFrame: 60 minutes after spinal block
measure: diastolic blood pressure
timeFrame: 60 minutes after spinal block
measure: heart rate
timeFrame: 60 minutes after spinal block
measure: intraoperative hypertension
timeFrame: 60 minutes after spinal block
measure: incidence of nausea and vomiting
timeFrame: 60 minutes after spinal block
measure: ephedrine consumption
timeFrame: 60 minutes after spinal block
measure: Atropine consumption
timeFrame: 60 minutes after spinal block
measure: APGAR score
timeFrame: 1 minute after delivery
measure: APGAR score
timeFrame: 10 minutes after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References: