A Phase 4 interventional study of Single shot phenylephrine and Fixed infusion phenylephrine. in Cesarean Section Complications and Spinal Anesthesia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Cairo University · Phase 4, Interventional, and Prevention
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.
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).
Exclusion Criteria:
Spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered.
Drug: Single shot phenylephrine · Drug: Bupivacaine
Spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred.
Drug: Fixed infusion phenylephrine. · Drug: Bupivacaine
Spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure.
Drug: Variable infusion phenylephrine. · Drug: Bupivacaine
A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
Also known as: Phenylephrine
Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
Also known as: Phenylephrine
Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
Also known as: Phenylephrine
Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
Also known as: Marcaine
Incidence of Post-spinal anesthesia hypotension
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
Incidence of severe Post-spinal anesthesia hypotension
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: 30 minutes after spinal anesthesia
Incidence of reactive hypertension
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
Systolic blood pressure measured in mmHg
Time frame: 2 hours after spinal anesthesia
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Time frame: 2 hours after spinal anesthesia
Heart rate
number of heart beats per minute
Time frame: 2 hours after spinal anesthesia
APGAR score
APGAR score of the fetus
Time frame: 10 minutes after delivery
umbilical arterial PH
the PH in umbilical arterial blood
Time frame: 10 minutes after delivery
umbilical arterial Pco2
umbilical arterial Pco2 measured in mmHg
Time frame: 10 minutes after delivery
Plan to share: Undecided
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Cairo University