Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Spinal Anesthetic Toxicity

Treatments: Drug: Norepinephrine 6 mcg; Drug: Norepinephrine 10 mcg; Drug: Bupivacaine hydrochloride; Drug: Norepinephrine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03792906

N71-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women
• Scheduled for cesarean delivery

Exclusion criteria

• Patients with severe cardiac dysfunction
• Patients with low blood pressure
• Patients with ante-partum bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

Norepinephrine 6 mcg

Experimental group

Description:

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

Treatment:

Drug: Norepinephrine infusion

Drug: Bupivacaine hydrochloride

Drug: Norepinephrine 6 mcg

Norepinephrine 10 mcg

Active Comparator group

Description:

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.

Treatment:

Drug: Norepinephrine infusion

Drug: Bupivacaine hydrochloride

Drug: Norepinephrine 10 mcg