Cesarean Section Complications
Conditions
Brief summary
three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.
Detailed description
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia). Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
Interventions
DRUGnorepinephrine infusion (0.025 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
DRUGnorepinephrine infusion (0.050 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
DRUGnorepinephrine infusion (0.075 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
DRUGBupivacaine
The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* full term * singleton * pregnant women * scheduled for elective cesarean delivery
Exclusion criteria
* cardiac morbidities * hypertensive disorders of pregnancy * peripartum bleeding * baseline systolic blood pressure (SBP) \< 100 mmHg * body mass index \> 35 will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postspinal hypotension | 30 minutes after spinal anesthesia | The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-delivery hypotension | 10 minutes after delivery | number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion) |
| systolic blood pressure | 60 minutes after spinal block | systolic blood pressure measured in mmHg |
| diastolic blood pressure | 60 minutes after spinal block | diastolic blood pressure measured in mmHg |
| heart rate | 60 minutes after spinal block | heart rate measured in beats per minute |
| severe postspinal hypotension | 30 minutes after spinal anesthesia | The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group |
| incidence of nausea and vomiting | 60 minutes after spinal block | number of patients who develop nausea and vomiting divided by the total number of patients in the group |
| ephedrine consumption | 60 minutes after spinal block | total amount of ephedrine consumed during the operation (measured in milligrams) |
| Atropine consumption | 60 minutes after spinal block | total amount of atropine consumed during the operation (measured in milligrams) |
| APGAR score | 1 minute after delivery | APGAR score for detection of the well being of the fetus |
| intraoperative hypertension | 60 minutes after spinal block | number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group |
Countries
Egypt
Outcome results
None listed