Cairo University
Cairo, Egypt
NCT Number: NCT03302039
The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.
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Notify Me18 year–40 year
Female
Interventional
Phase 4
Cairo, Egypt
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
Other names: Phenylephrine
Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
Other names: Phenylephrine
Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
Other names: Phenylephrine
Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
Other names: Marcaine
Time frame: 30 minutes after spinal anesthesia
Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus
Time frame: 30 minutes after spinal anesthesia
Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
Time frame: 2 hours after spinal anesthesia
Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
Time frame: 2 hours after spinal anesthesia
Systolic blood pressure measured in mmHg
Time frame: 2 hours after spinal anesthesia
Diastolic blood pressure measured in mmHg
Time frame: 2 hours after spinal anesthesia
number of heart beats per minute
Time frame: 10 minutes after delivery
APGAR score of the fetus
Time frame: 10 minutes after delivery
the PH in umbilical arterial blood
Time frame: 10 minutes after delivery
umbilical arterial Pco2 measured in mmHg
Cairo University
Other
Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery
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