Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
| Registry | NCT03248791 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 120 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Cesarean Section Complications, Spinal Anesthesia |
| Interventions | Phenylephrine, Norepinephrine, Bupivacaine (Drug) |
| Dates | start 2017-08-20, primary completion 2022-03-01 (estimated), completion 2022-03-10 (estimated), first posted 2017-08-14, last updated 2021-09-27 |
| Locations | 1 site in Egypt |
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Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Phenylephrine | Active comparator | Drug: Phenylephrine; Drug: Bupivacaine | Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
| Norepinephrine | Experimental | Drug: Norepinephrine; Drug: Bupivacaine | Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure |
Sex: Female, ages: 18 Years to 40 Years
Inclusion Criteria: * full term * pregnant women * scheduled for cesarean section Exclusion Criteria: * pre-ecpamsia * eclampsia * bleeding * cardiac dysfuction
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo University | Cairo | Egypt | Recruiting |