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NCT Number: NCT04404946

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

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Key information

Conditions

Hypotension Symptomatic Cesarean Section Complications Obstetric Anesthesia Problems Vasoconstriction

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, 115 28, Greece

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.

The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.

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

phenylephrine infusion

Other

in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

Other names: medication used for blood pressure maintenance

norepinephrine infusion

Other

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

Other names: medication used for blood pressure maintenance

placebo infusion

Other

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Other names: medication used for blood pressure maintenance

Primary outcomes

  1. incidence of bradycardia

    Time frame: intraoperative

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

  2. 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. number of bolus doses of vasoconstrictor administered

    Time frame: intraoperative

    number of interventions to maintain systolic blood pressure within the set limits will be recorded

  4. total dose of vasoconstrictor administered

    Time frame: intraoperative

    total dose in mg for ephedrine or μg for phenylephrine administered

  5. incidence of hypertension

    Time frame: intraoperative

    any incidence of systolic blood pressure>120% of baseline 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 minutes

    Time frame: 1 minute post delivery

    Neonatal Apgar score will be recorded at 1 minutes 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 minutes

    Time frame: 5 minutes post delivery

    Neonatal Apgar score will be recorded at 5 minutes 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 minute post delivery

    fetal cord blood analysis will be performed immediately post-delivery

  12. glucose in neonatal blood

    Time frame: 1 minute post delivery

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

  13. adrenaline in neonatal blood

    Time frame: 5 minutes post delivery

    an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements

  14. noradrenaline in neonatal blood

    Time frame: 5 minutes post delivery

    an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements

Other outcomes

  1. cardiac output

    Time frame: intraoperative

    cardiac output via non-invasive device (Nexfin) will be measured intraoperatively

  2. stroke volume

    Time frame: intraoperative

    stroke volume via non-invasive device (Nexfin) will be measured intraoperatively

  3. systemic vascular resistance

    Time frame: intraoperative

    systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study

Acronym: annie-zoe

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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