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Completed

NCT Number: NCT03182088

Norepinephrine Infusion Different Doses in Cesarean Delivery

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • full term
  • singleton
  • pregnant women
  • scheduled for elective cesarean delivery

Exclusion criteria

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • baseline systolic blood pressure (SBP) < 100 mmHg
  • body mass index > 35 will be excluded from the study.

Treatment and study plan

norepinephrine infusion (0.025 mcg/Kg/min)

Drug

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)

Other names: noradrenaline infusion

norepinephrine infusion (0.050 mcg/Kg/min)

Drug

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)

Other names: noradrenaline infusion

norepinephrine infusion (0.075 mcg/Kg/min)

Drug

The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).

Other names: noradrenaline infusion

Bupivacaine

Drug

The patient will receive spinal anesthesia using Bupivacaine (10 mg).

Other names: spinal anesthesia, Heavy marcaine

Primary outcomes

  1. postspinal hypotension

    Time frame: 30 minutes after spinal anesthesia

    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

Secondary outcomes

  1. severe postspinal hypotension

    Time frame: 30 minutes after spinal anesthesia

    The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

  2. Post-delivery hypotension

    Time frame: 10 minutes after delivery

    number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)

  3. systolic blood pressure

    Time frame: 60 minutes after spinal block

    systolic blood pressure measured in mmHg

  4. diastolic blood pressure

    Time frame: 60 minutes after spinal block

    diastolic blood pressure measured in mmHg

  5. heart rate

    Time frame: 60 minutes after spinal block

    heart rate measured in beats per minute

  6. intraoperative hypertension

    Time frame: 60 minutes after spinal block

    number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group

  7. incidence of nausea and vomiting

    Time frame: 60 minutes after spinal block

    number of patients who develop nausea and vomiting divided by the total number of patients in the group

  8. ephedrine consumption

    Time frame: 60 minutes after spinal block

    total amount of ephedrine consumed during the operation (measured in milligrams)

  9. Atropine consumption

    Time frame: 60 minutes after spinal block

    total amount of atropine consumed during the operation (measured in milligrams)

  10. APGAR score

    Time frame: 1 minute after delivery

    APGAR score for detection of the well being of the fetus

  11. APGAR score

    Time frame: 10 minutes after delivery

    APGAR score for detection of the well being of the fetus

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2017
Registry last updated
Aug 24, 2018

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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