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Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

Primary Purpose

Hypotension Drug-Induced

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ringer
Voluven
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension Drug-Induced

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age : 18-40 years
  • ASA 1&2

Exclusion Criteria:

  • Patients with morbid obesity.
  • Pre-existing or pregnancy-induced hypertension.
  • Known cardiovascular or cerebrovascular disease.
  • Abnormal CTG tracing.
  • Any other contraindications for intrathecal anaesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ringer

    Voluven

    Arm Description

    This group will receive 1 L of Ringer's solution as a preload

    This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload

    Outcomes

    Primary Outcome Measures

    Incidence of hypotension
    Decrease in systolic blood pressure more than 20% of base line

    Secondary Outcome Measures

    Perfusion index
    Derived from pulse oximeter
    Heart rate
    Urine output

    Full Information

    First Posted
    March 3, 2018
    Last Updated
    March 8, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03465943
    Brief Title
    Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
    Official Title
    Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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 aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section. To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.
    Detailed Description
    Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world. One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ). This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them. Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space. Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension Drug-Induced

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ringer
    Arm Type
    Active Comparator
    Arm Description
    This group will receive 1 L of Ringer's solution as a preload
    Arm Title
    Voluven
    Arm Type
    Active Comparator
    Arm Description
    This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
    Intervention Type
    Drug
    Intervention Name(s)
    Ringer
    Other Intervention Name(s)
    Crystalloid
    Intervention Description
    1L of Ringer's solution as a preload in one group.
    Intervention Type
    Drug
    Intervention Name(s)
    Voluven
    Other Intervention Name(s)
    Hydroxyethyl starch 6%
    Intervention Description
    500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
    Primary Outcome Measure Information:
    Title
    Incidence of hypotension
    Description
    Decrease in systolic blood pressure more than 20% of base line
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Perfusion index
    Description
    Derived from pulse oximeter
    Time Frame
    1 hour
    Title
    Heart rate
    Time Frame
    1 hour
    Title
    Urine output
    Time Frame
    1 hour

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age : 18-40 years ASA 1&2 Exclusion Criteria: Patients with morbid obesity. Pre-existing or pregnancy-induced hypertension. Known cardiovascular or cerebrovascular disease. Abnormal CTG tracing. Any other contraindications for intrathecal anaesthesia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Essam E. Abd El-Hakeem, PhD
    Phone
    01207159716
    Email
    Essam1993@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nagwa Mostafa Osman, PhD
    Phone
    01006792219
    Email
    nagwaosman1962@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25501602
    Citation
    Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
    Results Reference
    background
    PubMed Identifier
    15758080
    Citation
    Ngan Kee WD. Confidential enquiries into maternal deaths: 50 years of closing the loop. Br J Anaesth. 2005 Apr;94(4):413-6. doi: 10.1093/bja/aei069. No abstract available.
    Results Reference
    result

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    Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

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