Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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