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6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

Primary Purpose

Adverse Effect

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydroxyethyl starch 130/0.4
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Hydroxyethyl starch 130/0.4, Coload, Hypotension, Cesarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-40 years
  • Primipara or multipara
  • Singleton pregnancy ≥ 37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
  • Hemoglobin < 7g/dl
  • Coagulation or renal function disorders
  • Known allergy to hydroxyethyl starch
  • Fetal distress, or known fetal developmental anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hydroxyethyl starch (130/0.4) coload group

    Arm Description

    An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.

    Outcomes

    Primary Outcome Measures

    ED 50 and ED 90
    The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

    Secondary Outcome Measures

    The incidence of post-spinal anesthesia hypotension
    Systolic blood pressure (SBP) < 80% of the baseline
    The incidence of severe post-spinal anesthesia hypotension.
    Systolic blood pressure (SBP) < 60% of the baseline.
    The incidence of bradycardia.
    Heart rate < 60 beats/min.
    The incidence of nausea and vomiting.
    Presence of nausea and vomiting in patients after spinal anesthesia
    The incidence of hypertension.
    Systolic blood pressure (SBP) >120% of the baseline.
    pH
    From umbilical arterial blood gases.
    Partial pressure of oxygen (PO2)
    From umbilical arterial blood gases.
    Base excess (BE)
    From umbilical arterial blood gases.
    APGAR score
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    APGAR score
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Full Information

    First Posted
    July 25, 2022
    Last Updated
    July 26, 2022
    Sponsor
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05475886
    Brief Title
    6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension
    Official Title
    6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    April 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.
    Detailed Description
    Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Effect
    Keywords
    Hydroxyethyl starch 130/0.4, Coload, Hypotension, Cesarean section

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydroxyethyl starch (130/0.4) coload group
    Arm Type
    Experimental
    Arm Description
    An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyethyl starch 130/0.4
    Other Intervention Name(s)
    Colloid
    Intervention Description
    An initial infusion dose of 500 ml 6% Hydroxyethyl starch (130/0.4) coload simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 100 ml according to the responses of previous patients according to the up-down sequential allocation.
    Primary Outcome Measure Information:
    Title
    ED 50 and ED 90
    Description
    The dose of 6% Hydroxyethyl starch (130/0.4) that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
    Time Frame
    1-15 minutes after spinal anesthesia
    Secondary Outcome Measure Information:
    Title
    The incidence of post-spinal anesthesia hypotension
    Description
    Systolic blood pressure (SBP) < 80% of the baseline
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of severe post-spinal anesthesia hypotension.
    Description
    Systolic blood pressure (SBP) < 60% of the baseline.
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of bradycardia.
    Description
    Heart rate < 60 beats/min.
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of nausea and vomiting.
    Description
    Presence of nausea and vomiting in patients after spinal anesthesia
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of hypertension.
    Description
    Systolic blood pressure (SBP) >120% of the baseline.
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    pH
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    Partial pressure of oxygen (PO2)
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    Base excess (BE)
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    APGAR score
    Description
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    Time Frame
    1 min after delivery
    Title
    APGAR score
    Description
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    Time Frame
    5 min after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-40 years Primipara or multipara Singleton pregnancy ≥ 37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg Hemoglobin < 7g/dl Coagulation or renal function disorders Known allergy to hydroxyethyl starch Fetal distress, or known fetal developmental anomaly
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Chen, M.D.
    Phone
    86-951-674-3252
    Email
    czzyxgp@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi Chen, M.D.
    Organizational Affiliation
    General Hospital of Ningxia Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension

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