Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

Not Applicable

• Conditions: Gynecologic Disease
• Interventions: Drug: Mg (magnesium sulfate); Drug: Control (saline)

• Registration Number: NCT03541915
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-01
• Study Start: 2018-12-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mg group	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.
Control group	Control (saline)	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.

Primary Outcome Measures

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