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Completed

NCT Number: NCT03702400

Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery

This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Federal Dos Servidores Do Estado

Rio de Janeiro, 22451-030, Brazil

About this study

This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
  • Age above 18 years;
  • Physical State American Society of Anesthesiologists (ASA) II and III;
  • Weight between 50kg and 120kg;
  • Height between 140cm and 180cm.

Exclusion criteria

  • Refusal to participate in the study;
  • Pregnant women with fetus with known abnormalities;
  • Pregnant women with cardiovascular disease;
  • Pregnant women with pregnancy-specific hypertensive disease;
  • Allergy to any medication to be used in the study;
  • Users of monoamine oxidase inhibitors;
  • Users of tricyclic antidepressants;
  • Emergency caesarean section due to acute fetal distress;
  • Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia.

Treatment and study plan

Phenylephrine 100 mcg

Drug

Phenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus

Other names: Fenilefrin

Norepinephrine 5 mcg

Drug

Norepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus

Other names: Hemitartarato de norepinefrina

Primary outcomes

  1. Number of bolus required

    Time frame: during the procedure

    Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean

  2. Heart rate

    Time frame: during the procedure

    Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean

Secondary outcomes

  1. Neonatal gasometric outcome

    Time frame: during the procedure

    To evaluate the neonatal outcome through the analysis of venous and arterial blood gases collected in the cord umbilical after birth.

  2. Neonatal Apgar outcome

    Time frame: during the procedure

    To evaluate the neonatal outcome through the classification given by the neonatologist responsible for the care to the newborn in the delivery room with the use of the Apgar Scale (0-10), 10 the better classification.

  3. Nausea and vomiting

    Time frame: during the procedure

    To evaluate the incidence of nausea and vomiting of the parturient during cesarean section

Sponsors and collaborators

Lead sponsor

Hospital dos Servidores do Estado do Rio de Janeiro

Other Gov

Registry information

Official study title

Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2018
Registry last updated
Apr 13, 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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