Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery
Condition: Cesarean Section Complications; Spinal Anesthetic Toxicity
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10
      mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean
      delivery.
    

Detailed description: 
      Maternal hypotension after subarachnoid block is a frequent and deleterious complication
      during cesarean delivery. Although prophylaxis against hypotension using vasopressors had
      become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus;
      management of maternal hypotension using vasopressor boluses is usually needed .

      The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and
      recently norepinephrine. The use of ephedrine is usually accompanied with maternal
      tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and
      management of maternal hypotension; however, its use might result in bradycardia and
      decreased maternal cardiac output .

      Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity;
      thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine
      was introduced for use during cesarean delivery with promising results . Few previous studies
      investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension.
      A dose-response study had investigated the best dose of Norepinephrine for prevention of
      maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported
      as the best dose for prophylaxis against maternal hypotension.

      No studies had investigated the best bolus dose of norepinephrine for management of a
      maternal hypotensive episode. In this study the investigators will investigate the efficacy
      and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management
      of maternal hypotensive episode after subarachnoid block during cesarean delivery.
    

Intervention name(s): Norepinephrine 6 mcg; Norepinephrine 10 mcg; Norepinephrine infusion; Bupivacaine hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.; An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.; Prophylactic norepinephrine infusion will be started after subarachnoid block.; Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.
Other intervention name(s): Levophed; Levophed; Levophed; marcaine
Intervention MeSH terms: Norepinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment