Clinical trial NCT03792906: Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery
Official title: Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Spinal Anesthetic Toxicity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful management of maternal hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: Rate of successful management of severe maternal hypotension.
timeFrame: 30 minutes after spinal anesthesia
measure: Incidence of reactive hypertension
timeFrame: 30 minutes after spinal anesthesia
measure: Systolic blood pressure.
timeFrame: 2 hours after subarachnoid block
measure: Heart rate
timeFrame: 2 hours after subarachnoid block
measure: Apgar score for evaluation of the activity of the fetus
timeFrame: 10 minutes
measure: Umbilical blood acidity
timeFrame: 10 minutes after delivery
measure: The frequency of vomiting.
timeFrame: 2 hours after subarachnoid block
measure: Incidence of bradycardia
timeFrame: 2 hours after subarachnoid block
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Assistant professor of anesthesia
name: Ahmed M Hasanin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y.