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Clinical Trials/NCT03712111
NCT03712111
Unknown
Phase 4

Comparison of Vasopressor Boluses for Management of Hypotension After Spinal Anesthesia

Cairo University1 site in 1 country86 target enrollmentNovember 21, 2018

Overview

Phase
Phase 4
Intervention
Norepinephrine 6 mcg
Conditions
Cesarean Section Complications
Sponsor
Cairo University
Enrollment
86
Locations
1
Primary Endpoint
Rate of successful management of maternal hypotension
Last Updated
4 years ago

Overview

Brief Summary

In this study the investigators will compare the efficacy and side effects of 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.

Registry
clinicaltrials.gov
Start Date
November 21, 2018
End Date
July 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

Assistant professor of anesthesia and critical care

Cairo University

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

Arms & Interventions

Norepinephrine 6 mcg

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

Intervention: Norepinephrine 6 mcg

Norepinephrine 6 mcg

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

Intervention: Bupivacaine Hydrochloride

Norepinephrine 6 mcg

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

Intervention: Norepinephrine infusion

Norepinephrine 10 mcg

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

Intervention: Norepinephrine 10 mcg

Norepinephrine 10 mcg

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

Intervention: Bupivacaine Hydrochloride

Norepinephrine 10 mcg

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

Intervention: Norepinephrine infusion

Outcomes

Primary Outcomes

Rate of successful management of maternal hypotension

Time Frame: 30 minutes after spinal anesthesia

number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)

Secondary Outcomes

  • Rate of successful management of severe maternal hypotension(30 minutes after spinal anesthesia)
  • incidence of reactive hypertension(30 minutes after spinal anesthesia)
  • systolic blood pressure(90 minutes after spinal anesthesia)
  • heart rate(90 minutes after spinal block)
  • Apgar score for evaluation of the activity of the fetus(10 minutes)
  • Umbilical blood acidity(10 minutes after delivery)
  • The frequency of vomiting(90 minutes after spinal anesthesia)

Study Sites (1)

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