Magnesium Sulfate; Postoperative Nausea and Vomiting; Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

NCT03202459

Postoperative Complications Postoperative Nausea and Vomiting

UNKNOWN NA

Effect of Right-stellate Ganglion Block in Preventing Postoperative Nausea and Vomiting in Gynecological Laparoscopic Patients

NCT06426186

Postoperative Nausea and Vomiting

COMPLETED NA

Opioid-free Anesthesia in Gynecologic Surgery

NCT04700761

Gynecologic Disease

UNKNOWN NA

Sugammadex Versus Neostigmine for Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery

NCT02666014

Postoperative Nausea and Vomiting

COMPLETED PHASE3

Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

NCT01543945

Postoperative Nausea and Vomiting

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mg (magnesium sulfate)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Control (saline)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Masi Normal saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No