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

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ClinicalTrials.gov Identifier: NCT03729076
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Cesarean Delivery Hypotension Other: Crystalloid Other: Colloid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : January 8, 2020
Actual Study Completion Date : January 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crystalloid
Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.
Other: Crystalloid
Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

Active Comparator: Colloid
Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.
Other: Colloid
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Parturients
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729076


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital, Seoul National University College of Medicine
Publications:
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03729076    
Other Study ID Numbers: H-1807-152-961
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases