Cesarean Section Complications, Spinal Anesthesia
Conditions
Brief summary
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.
Detailed description
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).
Interventions
A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
DRUGFixed infusion phenylephrine.
Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
DRUGVariable infusion phenylephrine.
Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
DRUGBupivacaine
Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Full term * Pregnant women * Scheduled for cesarean delivery
Exclusion criteria
* Pre-eclampsia * Eclampsia * Hemorrhage * Cardiac dysfunction * Baseline low heart rate (below 60 bpm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-spinal anesthesia hypotension | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of reactive hypertension | 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. |
| Systolic blood pressure | 2 hours after spinal anesthesia | Systolic blood pressure measured in mmHg |
| Diastolic blood pressure | 2 hours after spinal anesthesia | Diastolic blood pressure measured in mmHg |
| Incidence of severe Post-spinal anesthesia hypotension | 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. |
| APGAR score | 10 minutes after delivery | APGAR score of the fetus |
| umbilical arterial PH | 10 minutes after delivery | the PH in umbilical arterial blood |
| umbilical arterial Pco2 | 10 minutes after delivery | umbilical arterial Pco2 measured in mmHg |
| Heart rate | 2 hours after spinal anesthesia | number of heart beats per minute |
Countries
Egypt
Outcome results
None listed