Cesarean Section Complications, Spinal Anesthesia
Conditions
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.
Interventions
DRUGPhenylephrine
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
DRUGNorepinephrine
Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
DRUGBupivacaine
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Full term * Pregnant women * Scheduled for cesarean section
Exclusion criteria
* Pre-eclampsia * Eclampsia * Bleeding * Cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-spinal anesthesia hypotension. | 30 minutes after spinal anesthesia | Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe post-spinal anesthesia hypotension | 30 minutes after spinal anesthesia | Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading |
| Incidence of severe delivery hypotension | 10 minutes after delivery | Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading |
| Systolic blood pressure | 2 hours after subarachnoid block | Systolic blood pressure measured in mmHg |
| Heart rate | 2 hours after subarachnoid block | number of heart beats per minute |
| APGAR score for assessment of the general state of the fetus | 10 minutes after delivery | APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score |
| Umbilical arterial potential hydrogen (PH) | 10 minutes after delivery | PH in the blood sample obtained from umbilical artery scaled from 1 to 14 |
| Incidence of reactive hypertension | 2 hours after spinal anesthesia | Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading |
| incidence of nausea | 2 hours | The percentage of patients with nausea |
| Incidence of vomiting | 2 hours | The percentage of patients with nausea |
| Total phenylephrine consumption | 2 hours | the total dose of phenylephrine consumed during the operation |
| Total norepinephrine consumption | 2 hours | the total dose of norepinephrine consumed during the operation |
| Total ephedrine consumption | 2 hours | the total dose of ephedrine consumed during the operation |
| Umbilical arterial Partial pressure of Carbon dioxide | 10 minutes after delivery | in the blood sample obtained from umbilical artery measured in mmHg |
Countries
Egypt
Outcome results
None listed