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Effect of Magnesium on Remifentanil Induced Cough

Primary Purpose

Cough

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Magnesium sulfate
Placebo
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cough

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2

Exclusion Criteria:

  • When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.)
  • If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60)
  • If you are taking opioid analgesics or magnesium for other reasons
  • Patients with hypermagnesemia
  • Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders
  • Pregnant or lactating women
  • Patients with myasthenia gravis
  • Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin)
  • In case of hypersensitivity to magnesium
  • Patients with a history of hypersensitivity to propofol and any of its components
  • Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    magnesium group

    control group

    Arm Description

    magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)

    normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion)

    Outcomes

    Primary Outcome Measures

    remifentanil induced cough
    To evaluate whether coughing occurs during anesthesia induction from the start of remifentanil infusion to the completion of laryngeal mask insertion.

    Secondary Outcome Measures

    severity of cough
    mild: 1-2, moderate: 3-4, severe: ≥ 5
    laryngeal mask airway (LMA) insertion compliance
    Assess the number of trials prior to successful laryngeal mask insertion and the need for administration of a neuromuscular blocker.
    lung compliance
    Poor compliance of mechanical ventilation is defined as a difference between the set tidal volume and the actual tidal volume value applied to the patient by 100ml or more.

    Full Information

    First Posted
    January 29, 2022
    Last Updated
    February 11, 2022
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05237791
    Brief Title
    Effect of Magnesium on Remifentanil Induced Cough
    Official Title
    Effect of Magnesium Sulfate on Remifentanil Induced Cough and Chest Wall Rigidity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 3, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    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 hypothesis of this study is that Magnesium sulfate pretreatment (50mg/kg) will reduce the incidence of cough and chest wall rigidity caused by remifentanil administration. The purpose of this study was to investigate the effect of magnesium sulfate administered before induction of anesthesia on thoracic stiffness and cough response caused by opioid analgesics administered for general anesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cough

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    magnesium group
    Arm Type
    Experimental
    Arm Description
    magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    normal saline 100ml (loading for 10 minutes), 15mg/kg/hr (continuous infusion)
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Intervention Description
    magnesium sulphate 50mg/kg (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    normal saline 100ml (loading dose for 10 minutes), 15mg/kg/hr (continuous infusion)
    Primary Outcome Measure Information:
    Title
    remifentanil induced cough
    Description
    To evaluate whether coughing occurs during anesthesia induction from the start of remifentanil infusion to the completion of laryngeal mask insertion.
    Time Frame
    from preoperative 20 minutes to induction of anesthesia
    Secondary Outcome Measure Information:
    Title
    severity of cough
    Description
    mild: 1-2, moderate: 3-4, severe: ≥ 5
    Time Frame
    from preoperative 20 minutes to induction of anesthesia
    Title
    laryngeal mask airway (LMA) insertion compliance
    Description
    Assess the number of trials prior to successful laryngeal mask insertion and the need for administration of a neuromuscular blocker.
    Time Frame
    from preoperative 20 minutes to induction of anesthesia
    Title
    lung compliance
    Description
    Poor compliance of mechanical ventilation is defined as a difference between the set tidal volume and the actual tidal volume value applied to the patient by 100ml or more.
    Time Frame
    from induction of anesthesia to finish of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 20-75 years of age who are undergoing surgery under general anesthesia using a laryngeal mask and who have consented to participate in this study among American Society of Anesthesiologists body grade 1 or 2 Exclusion Criteria: When coughing may occur due to an underlying disease (upper respiratory infection, rhinitis, post nasal drip, asthma, chronic obstructive pulmonary disease, pneumonia, bronchitis, current smokers, etc.) If you have kidney disease that can affect magnesium metabolism (glomerular filtration rate less than 60) If you are taking opioid analgesics or magnesium for other reasons Patients with hypermagnesemia Patients with atrioventricular block (stages I-III) or other cardiac conduction disorders Pregnant or lactating women Patients with myasthenia gravis Patients taking drugs that are contraindicated or interact with magnesium (barbitalates, aminoglycoside antibiotics, isoniazid, chlorpromazine, digoxin) In case of hypersensitivity to magnesium Patients with a history of hypersensitivity to propofol and any of its components Patients with a history of hypersensitivity to remifentanil and other fentanyl analogues

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Magnesium on Remifentanil Induced Cough

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