Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Spinal Anesthesia

Treatments: Drug: Norepinephrine; Drug: Bupivacaine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03328533

N-82-2017

Details and patient eligibility

About

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Full description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. 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 PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Enrollment: 123 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full term
• Pregnant women
• Scheduled for cesarean section

Exclusion criteria

• Pre-eclampsia
• Eclampsia
• Bleeding
• Cardiac dysfunction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups

Phenylephrine

Active Comparator group

Description:

Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Treatment:

Drug: Phenylephrine

Drug: Bupivacaine

Norepinephrine

Experimental group

Description:

Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Treatment:

Drug: Bupivacaine

Drug: Norepinephrine