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Completed

NCT Number: NCT04406051

Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra General Hospital of Athens, Athens, Greece

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About this study

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.

The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult parturients, American Society of Anesthesiologists (ASA) I-II,
  • singleton gestation>37 weeks
  • elective cesarean section

Exclusion criteria

  • Body Mass Index (BMI) >40 kg/m2
  • Body weight <50 kg
  • Body weight>100 kg
  • height<150 cm
  • height>180 cm
  • multiple gestation
  • fetal abnormality
  • fetal distress
  • active labor
  • cardiac disease
  • pregnancy-induced hypertension
  • thrombocytopenia
  • coagulation abnormalities
  • use of antihypertensive medication during pregnancy
  • communication or language barriers
  • lack of informed consent
  • contraindication for regional anesthesia

Treatment and study plan

norepinephrine infusion and colloid preloading (NOR-COL)

Procedure

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia

norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

Procedure

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia

Primary outcomes

  1. incidence of hypotension

    Time frame: intraoperative

    any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded

Secondary outcomes

  1. need for vasoconstrictor

    Time frame: intraoperative

    any need for vasoconstrictor during the operation will be recorded

  2. type of vasoconstrictor administered

    Time frame: intraoperative

    phenylephrine versus ephedrine

  3. total dose of vasoconstrictor administered

    Time frame: intraoperative

    total dose in mg for ephedrine or μg for phenylephrine administered

  4. incidence of hypertension

    Time frame: intraoperative

    any incidence of systolic blood pressure>120% of baseline will be recorded

  5. incidence of bradycardia

    Time frame: intraoperative

    any incidence of maternal bradycardia (heart rate<60/min) will be recorded

  6. need for atropine

    Time frame: intraoperative

    any need for atropine during the operation because of bradycardia will be recorded

  7. modification or cessation of the infusion

    Time frame: intraoperative

    any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded

  8. incidence of nausea/vomiting

    Time frame: intraoperative

    any occurence of nausea and/or vomiting during the operation will be recorded

  9. Neonatal Apgar score at 1 min

    Time frame: 1 min post delivery

    Neonatal Apgar score will be recorded at 1 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

  10. Neonatal Apgar score at 5 min

    Time frame: 5 min post delivery

    Neonatal Apgar score will be recorded at 5 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

  11. neonatal blood gases

    Time frame: 1 min post delivery

    fetal cord blood analysis will be performed immediately post-delivery

  12. glucose in neonatal blood

    Time frame: 1 min post delivery

    glucose will be measured in the cord blood gas sample taken immediately post-delivery

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Collaborators

  • Alexandra Hospital, Athens, Greece

Registry information

Official study title

Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?

Acronym: annie-manos

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 28, 2020
Registry last updated
Jun 15, 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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