Clinical trial NCT03328533: Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery
Official title: Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Full term
* Pregnant women
* Scheduled for cesarean section

Exclusion Criteria:

* Pre-eclampsia
* Eclampsia
* Bleeding
* Cardiac dysfunction

Primary outcomes:
measure: Incidence of post-spinal anesthesia hypotension.
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: Incidence of severe post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: Incidence of severe delivery hypotension
timeFrame: 10 minutes after delivery
measure: Systolic blood pressure
timeFrame: 2 hours after subarachnoid block
measure: Heart rate
timeFrame: 2 hours after subarachnoid block
measure: APGAR score for assessment of the general state of the fetus
timeFrame: 10 minutes after delivery
measure: Incidence of reactive hypertension
timeFrame: 2 hours after spinal anesthesia
measure: Umbilical arterial potential hydrogen (PH)
timeFrame: 10 minutes after delivery
measure: Umbilical arterial Partial pressure of Carbon dioxide
timeFrame: 10 minutes after delivery
measure: incidence of nausea
timeFrame: 2 hours
measure: Incidence of vomiting
timeFrame: 2 hours
measure: Total phenylephrine consumption
timeFrame: 2 hours
measure: Total norepinephrine consumption
timeFrame: 2 hours
measure: Total ephedrine consumption
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed M Mukhtar, Professor
role: STUDY_DIRECTOR
References: