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Completed

NCT Number: NCT03729076

Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.

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Key information

Conditions

Pregnancy Cardiovascular Diseases Cesarean Delivery Hypotension Vascular Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.

Exclusion criteria

  • multiple pregnancy
  • gestational age < 36 weeks
  • preexisting or pregnancy-induced hypertension
  • Morbid cardiovascular impairments
  • Cerebrovascular disease

⑥ Known fetal anomaly

⑦ Contraindications to spinal anesthesia

⑧ Any sign of onset of labor

⑨ Body weight < 45 kg or body weight > 90 kg

⑩ Height < 145cm or height > 180cm

Treatment and study plan

crystalloid

Other

Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

colloid

Other

Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

Primary outcomes

  1. Incidence of maternal hypotension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP

Secondary outcomes

  1. incidence of severe hypotension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP

  2. incidence of symptomatic hypotension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness

  3. incidence of bradycardia

    Time frame: during the time period from induction of spinal anesthesia until delivery

    Heart Rate (HR) <50 bpm

  4. incidence of Hypertension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    Systolic Blood Pressure (SBP)> 120% of baseline SBP

  5. Minimum recorded Systolic Blood Pressure (Minimum SBP)

    Time frame: during the time period from induction of spinal anesthesia until delivery

    The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery

  6. Minimum recorded Heart Rate (Minimum HR)

    Time frame: during the time period from induction of spinal anesthesia until delivery

    The lowest recorded HR during the time period from induction of spinal anesthesia until delivery

  7. Cumulative duration of hypotension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    duration of hypotension, minutes

  8. Onset time of hypotension

    Time frame: during the time period from induction of spinal anesthesia until delivery

    Time from the induction of spinal anesthesia until the first event of hypotension occur

  9. Total phenylephrine use

    Time frame: during the time period from induction of spinal anesthesia until delivery

    Cumulative dose of phenylephrine administered via continuous infusion, mcg

  10. Rescue phenylephrine use

    Time frame: during the time period from induction of spinal anesthesia until delivery

    number of patients who require the rescue use of phenylephrine

  11. Rescue ephedrine use

    Time frame: during the time period from induction of spinal anesthesia until delivery

    number of patients who require the rescue use of ephedrine

  12. Atropine use

    Time frame: during the time period from induction of spinal anesthesia until delivery

    number of patients who require the rescue use of atropine

  13. Incidence of nausea, vomiting

    Time frame: during the time period from induction of spinal anesthesia until delivery

    The incidence of nausea, vomiting

  14. Incidence of dizziness, breathlessness

    Time frame: during the time period from induction of spinal anesthesia until delivery

    The incidence of dizziness, breathlessness

  15. Cutaneous stellate ganglion sympathetic activity

    Time frame: during the time period from induction of spinal anesthesia until delivery

    noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes

  16. Apgar Score, 1 min, 5 min (fetal outcome)

    Time frame: 1 min, 5 min after delivery

    Apgar Score of delivered baby. 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. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.

  17. Umbilical arterial pH

    Time frame: immediately after delivery

    pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)

  18. Umbilical arterial base excess

    Time frame: immediately after delivery

    base excess of Umbilical ABGA (fetal outcome), mmol/L

  19. Umbilical arterial partial oxygen pressure (PO2)

    Time frame: immediately after delivery

    partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg

  20. Umbilical arterial carbon dioxide partial pressure (PCO2)

    Time frame: immediately after delivery

    carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2018
Registry last updated
Feb 5, 2020

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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