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Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03541915
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Do-Hyeong Kim, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Gynecologic Disease Drug: Mg (magnesium sulfate) Drug: Control (saline) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Intravenous Magnesium Sulfate on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mg group
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.
Drug: Mg (magnesium sulfate)
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.
Other Name: Masi

Placebo Comparator: Control group
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.
Drug: Control (saline)
The same volume of normal saline will be infused after induction of anesthesia and continuously infused at the same rate of magnesium.
Other Name: Normal saline




Primary Outcome Measures :
  1. The incidence of PONV [ Time Frame: up to postoperative 2 days ]
    The incidence of PONV will be measured up to postoperative 2 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Do-Hyeong Kim, Department of Anesthesiology and Pain Medicine, Assistant Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03541915     History of Changes
Other Study ID Numbers: 3-2018-0066
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Genital Diseases, Female
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Magnesium Sulfate
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents