Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

Yonsei University Health System (YUHS)

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Drug: Control (saline); Drug: Mg (magnesium sulfate)

Study type: Interventional

Funder types: Other

Identifiers

NCT03541915

3-2018-0066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Mg group

Experimental group

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.

Treatment:

Drug: Mg (magnesium sulfate)

Control group

Placebo Comparator group

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.

Treatment:

Drug: Control (saline)