Cesarean Section Complications
Conditions
Brief summary
Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal 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 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 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, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.
Interventions
DRUGNorepinephrine 0.05 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUGNorepinephrine 0.1 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUGNorepinephrine 0.15 mcg /Kg/min
Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
DRUGBupivacaine
10 mg Bupivacaine intra-thecal 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 singleton pregnant women * Scheduled for elective Cesarean Delivery * Aged between 18 and 40 years
Exclusion criteria
* Cardiac morbidities * Hypertensive disorders of pregnancy, * Peripartum bleeding * Baseline systolic blood pressure (SBP) \< 100 mmHg * Body mass index \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of 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 |
|---|---|---|
| vomiting | 120 minutes after spinal anesthesia | incidence of vomiting after spinal anesthesia |
| nausea | 120 minutes after spinal anesthesia | incidence of nausea after spinal anesthesia |
| ephedrine consumption | 60 minutes after spinal anesthesia | total amount of ephedrine consumed after spinal anesthesia |
| heart rate | 90 minutes after spinal anesthesia | heart rate after spinal anesthesia measured in beat per minute |
| APGAR score | 10 minutes after delivery | APGAR score of the delivered fetus |
| incidence of 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 |
| arterial blood pressure | 90 minutes after spinal anesthesia | arterial blood pressure after spinal anesthesia measured in mmHg |
| Atropine consumption | 60 minutes after spinal anesthesia | total amount of atropine consumed after spinal anesthesia |
Countries
Egypt
Outcome results
None listed