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NCT Number: NCT03792906

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

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.

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Key information

Conditions

Cesarean Section Complications Spinal Anesthetic Toxicity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norepinephrine 6 mcg

Drug

An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

Other names: Levophed

Norepinephrine 10 mcg

Drug

An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.

Other names: Levophed

Norepinephrine infusion

Drug

Prophylactic norepinephrine infusion will be started after subarachnoid block.

Other names: Levophed

Bupivacaine Hydrochloride

Drug

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.

Other names: marcaine

Primary outcomes

  1. 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

  1. Rate of successful management of severe maternal hypotension.

    Time frame: 30 minutes after spinal anesthesia

    number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).

  2. Incidence of reactive hypertension

    Time frame: 30 minutes after spinal anesthesia

    number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).

  3. Systolic blood pressure.

    Time frame: 2 hours after subarachnoid block

    Systolic blood pressure measured in mmHg.

  4. Heart rate

    Time frame: 2 hours after subarachnoid block

    Number of heart beats per minute.

  5. Apgar score for evaluation of the activity of the fetus

    Time frame: 10 minutes

    the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10.

  6. Umbilical blood acidity

    Time frame: 10 minutes after delivery

    the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.

  7. The frequency of vomiting.

    Time frame: 2 hours after subarachnoid block

    The number of patients with vomiting.

  8. Incidence of bradycardia

    Time frame: 2 hours after subarachnoid block

    number of patients with bradycardia (defined as heart rate less than 55 beat per minute after administration of norepinephrine bolus).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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