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Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine

Primary Purpose

Adverse Effect

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydroxyethyl starch coload - 0 ml/kg
Hydroxyethyl starch coload - 5 ml/kg
Hydroxyethyl starch coload - 10 ml/kg
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 Norepinephrine, Hydroxyethyl starch 130/0.4, Postspinal anesthesia hypotension, Coload, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18-45 years Primipara or multipara Singleton pregnancy ≥37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for 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 ≥180 mmHg Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    0 ml/kg Hydroxyethyl starch coload group

    5 ml/kg Hydroxyethyl starch coload group

    10 ml/kg Hydroxyethyl starch coload group

    Arm Description

    No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia

    5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

    10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.

    Outcomes

    Primary Outcome Measures

    ED 50
    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients
    ED 90
    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 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
    January 10, 2023
    Last Updated
    February 27, 2023
    Sponsor
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05712018
    Brief Title
    Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine
    Official Title
    Comparison of Different 6% Hydroxyethyl Starch (130/0.4) Coload Volumes on the 90% Effective Dose of Norepinephrine Infusion Prophylaxis for Hypotension During Spinal Anesthesia for Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 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 effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for 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. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0 ml/kg Hydroxyethyl starch coload group
    Arm Type
    Experimental
    Arm Description
    No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia
    Arm Title
    5 ml/kg Hydroxyethyl starch coload group
    Arm Type
    Experimental
    Arm Description
    5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
    Arm Title
    10 ml/kg Hydroxyethyl starch coload group
    Arm Type
    Experimental
    Arm Description
    10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyethyl starch coload - 0 ml/kg
    Other Intervention Name(s)
    Colloid
    Intervention Description
    No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyethyl starch coload - 5 ml/kg
    Other Intervention Name(s)
    Colloid
    Intervention Description
    5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxyethyl starch coload - 10 ml/kg
    Other Intervention Name(s)
    Colloid
    Intervention Description
    10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
    Primary Outcome Measure Information:
    Title
    ED 50
    Description
    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) of patients
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    ED 90
    Description
    The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 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
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-45 years Primipara or multipara Singleton pregnancy ≥37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for 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 ≥180 mmHg Hemoglobin < 7g/dl 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
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiangsheng Xiong, M.D.
    Email
    158193942@qq.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
    First Name & Middle Initial & Last Name & Degree
    Xiangsheng Xiong, M.D.
    Organizational Affiliation
    The Fifth People's Hospital of Huaian
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine

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