Vasopressor Infusion in Cesarean Delivery

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Cesarean Section Complications; Spinal Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03248791

N-86-2017

Details and patient eligibility

About

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively 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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

Enrollment: 120 estimated 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-ecpamsia
• eclampsia
• bleeding
• cardiac dysfuction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 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

Treatment:

Drug: Phenylephrine

Drug: Bupivacaine

Norepinephrine

Experimental group

Description:

Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure

Treatment:

Drug: Norepinephrine

Drug: Bupivacaine