Vasopressor Prophylaxis After Spinal Anesthesia

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications

Treatments: Drug: Norepinephrine 0.1 mcg /Kg/min; Drug: Norepinephrine 0.15 mcg /Kg/min; Drug: Bupivacaine; Drug: Norepinephrine 0.05 mcg /Kg/min

Study type: Interventional

Funder types: Other

Identifiers

NCT03234816

N_66_2017

Details and patient eligibility

About

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.

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 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.

Enrollment: 270 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
• Aged between 18 and 40 years

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 3 patient groups

- 0.05 mcg /Kg/min group

Experimental group

Description:

will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Treatment:

Drug: Norepinephrine 0.05 mcg /Kg/min

Drug: Bupivacaine

- 0.1 mcg /Kg/min group

Experimental group

Description:

will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Treatment:

Drug: Bupivacaine

Drug: Norepinephrine 0.1 mcg /Kg/min

- 0.15 mcg /Kg/min group

Experimental group

Description:

will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus

Treatment:

Drug: Bupivacaine

Drug: Norepinephrine 0.15 mcg /Kg/min