Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03541915
• Other study ID #: 3-2018-0066
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2018
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• Control (saline)
The same volume of normal saline will be infused after induction of anesthesia and continuously infused at the same rate of magnesium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of PONV	The incidence of PONV will be measured up to postoperative 2 days.	up to postoperative 2 days