Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

NCT03541915 | Unknown

• 1 other identifier: 3-2018-0066
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• The incidence of PONV

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

  up to postoperative 2 days

Study Arms (2)

Mg group

EXPERIMENTAL

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)

Control group

PLACEBO COMPARATOR

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)

Interventions

Mg (magnesium sulfate) DRUG

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.

Also known as: Masi

Mg group

Control (saline) DRUG

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

Also known as: Normal saline

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gynecologic disease
• Female patients undergoing laparoscopic gynecologic surgery and receiving postoperative fentanyl based intravenous patient controlled analgesia (PCA), aged 20-65 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Magnesium Sulfate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Pain Medicine, Assistant Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 31, 2018
• Study Start: December 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: October 1, 2018

Record last verified: 2018-09