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Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

Primary Purpose

Gynecologic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mg (magnesium sulfate)
Control (saline)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gynecologic Disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gynecologic disease
  • Female patients undergoing laparoscopic gynecologic surgery and receiving postoperative fentanyl based intravenous patient controlled analgesia (PCA), aged 20-65 years.

Exclusion Criteria:

  • impaired renal or hepatic function (Glutamic Oxalacetate Transaminase [GOT]/Glutamic Pyruvate Transaminase [GPT]>50, estimated glomerular filtration rate [eGFR]<60)
  • atrioventricular block, myopathies, diabetes, treated with calcium channel blockers
  • History of receiving antiemetics within 1 day before surgery
  • History of receiving opioids or non-steroidal anti-inflammatory drugs within 1 week of surgery
  • drugs or alcohol abuse
  • patients treated with isoniazid, chlorpromazine, or digoxin
  • patients who cannot communicated with others or with cognitive dysfunction
  • patients who cannot read informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mg group

    Control group

    Arm Description

    20mg/kg of magnesium sulfate will be infused after induction of anesthesia. And magnesium sulfated will be continuously infused at a rate of 15mg/kg/h during the operation.

    Same volume of normal saline will be infused after induction of anesthesia. And the same volume of normal saline will be continuously infused at a same rate of magnesium during the operation.

    Outcomes

    Primary Outcome Measures

    The incidence of PONV
    The incidence of PONV will be measured up to postoperative 2 days.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2018
    Last Updated
    September 28, 2018
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03541915
    Brief Title
    Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery
    Official Title
    The Effect of Intravenous Magnesium Sulfate on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    May 30, 2019 (Anticipated)
    Study Completion Date
    May 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Postoperative nausea and vomiting (PONV) is commonly accompanied in patients undergoing surgery under general anesthesia. The patients undergoing laparoscopic gynecologic surgery have multiple risk factors for developing PONV such as female gender, nonsmoker, postoperative opioids, and laparoscopic surgery. Thus, it is important to prevent PONV in these patients.
    Detailed Description
    Magnesium is a N-methyl-D-aspartate (NMDA) antagonist that is known to be effective in reducing opioid consumption and controlling postoperative pain. This opioid reducing effect can be associated with reduction of the incidence of PONV. However, the effect of magnesium on preventing PONV have not been investigated before. Thus, the investigators hypothesized that intraoperative infusion of magnesium will be effective in preventing PONV in patients undergoing laparoscopic gynecologic surgery.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mg group
    Arm Type
    Experimental
    Arm Description
    20mg/kg of magnesium sulfate will be infused after induction of anesthesia. And magnesium sulfated will be continuously infused at a rate of 15mg/kg/h during the operation.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Same volume of normal saline will be infused after induction of anesthesia. And the same volume of normal saline will be continuously infused at a same rate of magnesium during the operation.
    Intervention Type
    Drug
    Intervention Name(s)
    Mg (magnesium sulfate)
    Other Intervention Name(s)
    Masi
    Intervention Description
    20mg/kg of magnesium sulfate will be infused after induction of anesthesia. And magnesium sulfated will be continuously infused at a rate of 15mg/kg/h during the operation.
    Intervention Type
    Drug
    Intervention Name(s)
    Control (saline)
    Other Intervention Name(s)
    Normal saline
    Intervention Description
    The same volume of normal saline will be infused after induction of anesthesia and continuously infused at the same rate of magnesium.
    Primary Outcome Measure Information:
    Title
    The incidence of PONV
    Description
    The incidence of PONV will be measured up to postoperative 2 days.
    Time Frame
    up to postoperative 2 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gynecologic disease Female patients undergoing laparoscopic gynecologic surgery and receiving postoperative fentanyl based intravenous patient controlled analgesia (PCA), aged 20-65 years. Exclusion Criteria: impaired renal or hepatic function (Glutamic Oxalacetate Transaminase [GOT]/Glutamic Pyruvate Transaminase [GPT]>50, estimated glomerular filtration rate [eGFR]<60) atrioventricular block, myopathies, diabetes, treated with calcium channel blockers History of receiving antiemetics within 1 day before surgery History of receiving opioids or non-steroidal anti-inflammatory drugs within 1 week of surgery drugs or alcohol abuse patients treated with isoniazid, chlorpromazine, or digoxin patients who cannot communicated with others or with cognitive dysfunction patients who cannot read informed consent

    12. IPD Sharing Statement

    Learn more about this trial

    Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

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