Lidocaine vs Magnesium Sulfate for Hemodynamic Stability During Emergence in Infertility-Related Laparoscopic Surgery" (LidoMagGyna)

Zagazig University

Status: Not yet enrolling

Conditions: Hemodynamic Instability; Infertility Female

Treatments: Drug: Normal Saline (Intravenous); Drug: magnesium sulfate; Drug: Lidocaine (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT07359560

ZU-IRB# 1904/2-Nov -2025

ethics commitee approval numbe (Other Identifier)

Details and patient eligibility

About

This study is being conducted to compare two medications, intravenous lidocaine and intravenous magnesium sulfate, and their ability to keep blood pressure and heart rate stable during the period of waking up from general anesthesia in infertility-related laparoscopic gynecologic surgeries.

Laparoscopic gynecologic procedures can cause changes in heart rate and blood pressure, especially during emergence from anesthesia, and these changes may affect patient safety.

In this randomized, double-blind clinical trial, women scheduled for elective infertility-related laparoscopic surgery will be assigned to one of three groups: lidocaine, magnesium sulfate, or a control group. The study will evaluate mean arterial pressure (primary outcome), heart rate, pain scores, sedation level, nausea and vomiting, and any side effects during and after surgery.

The goal is to determine which medication provides better hemodynamic stability and improves recovery in the early postoperative period.

Full description

Laparoscopic gynecologic procedures performed for infertility are commonly associated with significant changes in heart rate and blood pressure, especially during the emergence phase of general anesthesia. These hemodynamic fluctuations may increase the risk of discomfort, delayed recovery, or cardiovascular complications. Several medications, including lidocaine and magnesium sulfate, have been suggested to help stabilize these responses because of their analgesic, sympatholytic, and cardioprotective properties. However, there is limited evidence comparing the two drugs in this specific surgical population.This prospective, randomized, double-blind controlled trial aims to evaluate the effects of intravenous lidocaine and intravenous magnesium sulfate on hemodynamic stability during emergence from general anesthesia in women undergoing elective infertility-related laparoscopic gynecologic surgeries. Participants will be randomly assigned to one of three groups: a lidocaine group, a magnesium sulfate group, or a control group receiving normal saline. Study medications will be administered 30 minutes before the anticipated time of extubation.

Hemodynamic measurements will be recorded throughout the perioperative period, with particular focus on mean arterial pressure during emergence (primary outcome). Secondary measures include heart rate, postoperative pain scores, sedation levels, nausea and vomiting, and any adverse events observed within the first 24 hours after surgery. All patients will receive standardized anesthesia management, monitoring, and postoperative care.

The goal of the study is to identify which medication is more effective in maintaining stable hemodynamics and improving early recovery following laparoscopic gynecologic surgery for infertility.

Enrollment: 69 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Female patients aged 21 to 40 years

Body mass index (BMI) between 18.5 and 29 kg/m²

American Society of Anesthesiologists (ASA) physical status I or II

Scheduled for elective infertility-related laparoscopic gynecologic surgery (e.g., diagnostic laparoscopy, ovarian cystectomy, adhesiolysis) under general anesthesia

Expected duration of anesthesia less than 2 hours

Ability to provide written informed consent

Exclusion criteria

Known allergy or contraindication to lidocaine or magnesium sulfate

History of significant cardiac, renal, or hepatic disease

Chronic use of analgesics or history of drug dependence

History of myasthenia gravis

Pregnancy or positive serum β-hCG test

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 3 patient groups, including a placebo group

Arm 1: Control Group (Normal Saline)

Placebo Comparator group

Description:

Participants in this arm will receive 15 mL of 0.9% normal saline intravenously over 15 minutes, starting 30 minutes before the anticipated time of extubation. This serves as the control intervention for comparison with lidocaine and magnesium sulfate.

Treatment:

Drug: Normal Saline (Intravenous)

Arm 2: Lidocaine Group

Experimental group

Description:

Participants in this arm will receive intravenous lidocaine at a dose of 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the expected time of extubation.

Treatment:

Drug: Lidocaine (drug)

Drug: Lidocaine (drug)

Arm 3: Magnesium Sulfate Group

Experimental group

Description:

Participants in this arm will receive intravenous magnesium sulfate at a dose of 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL. The infusion will be administered over 15 minutes, starting 30 minutes before the anticipated time of extubation.

Treatment:

Drug: magnesium sulfate