Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

September 28, 2018 updated by: Do-Hyeong Kim, Gangnam Severance Hospital

The Effect of Intravenous Magnesium Sulfate on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of PONV
Time Frame: up to postoperative 2 days
The incidence of PONV will be measured up to postoperative 2 days.
up to postoperative 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

May 30, 2019

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2018-0066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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