Norepinephrine Infusion Different Doses in Cesarean Delivery

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications

Treatments: Drug: Bupivacaine; Drug: norepinephrine infusion (0.050 mcg/Kg/min); Drug: norepinephrine infusion (0.025 mcg/Kg/min); Drug: norepinephrine infusion (0.075 mcg/Kg/min)

Study type: Interventional

Funder types: Other

Identifiers

NCT03182088

N-49-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 3 patient groups

0.025 mcg /Kg/min group

Experimental group

Description:

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).

Treatment:

Drug: norepinephrine infusion (0.025 mcg/Kg/min)

Drug: Bupivacaine

0.050 mcg/Kg/min group

Experimental group

Description:

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).

Treatment:

Drug: norepinephrine infusion (0.050 mcg/Kg/min)

Drug: Bupivacaine

0.075 mcg/Kg/min group

Experimental group

Description:

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)

Treatment:

Drug: norepinephrine infusion (0.075 mcg/Kg/min)

Drug: Bupivacaine