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

January 13, 2026 updated by: Amira S kenawy ,md, Zagazig University

Intravenous Lidocaine Versus Magnesium Sulfate for Hemodynamic Stability During Emergence From General Anesthesia in Infertility-related Laparoscopic Gynecologic Surgeries

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 1: Control Group (Normal Saline)
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.
Drug: Normal Saline (Intravenous)
0.9% normal saline, total volume 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.
Experimental: Arm 2: Lidocaine Group
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.
Drug: Lidocaine (drug)
The intervention described in this clinical study involves a comparative prospective randomized double-blind controlled trial to assess the effects of intravenous Lidocaine versus Magnesium Sulfate compared to a Control group for hemodynamic stability during emergence from general anesthesia in infertility-related laparoscopic gynecologic surgeries.
Other Names:
  • saline
  • magnisium sulfate
Drug: Lidocaine (drug)
Lidocaine 1.5 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.
Experimental: Arm 3: Magnesium Sulfate Group
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.
Drug: magnesium sulfate
Magnesium sulfate 30 mg/kg diluted with 0.9% normal saline to a total volume of 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean arterial pressure
Time Frame: 6 months
MAP mean arterial pressure Measurement Schedule During Emergence MAP will be continuously monitored during the emergence phase of anesthesia. Recordings will be documented at minute 0 (the exact moment of extubation) and 5 minutes after extubation, starting from 5 minutes before extubation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: Preoperative: Baseline HR measurement. Intraoperative: 5 minutes after intubation. After Trendelenburg position. After pneumoperitoneum. Every 5 minutes for 30 minutes after infusion of lidocaine or magnesium sulfate. Emergence from Anesthesia:
HR heart rate serves as an important measure to determine how well the interventions (lidocaine or magnesium sulfate) manage hemodynamic stability during the delicate phase of emergence from anesthesia.
Preoperative: Baseline HR measurement. Intraoperative: 5 minutes after intubation. After Trendelenburg position. After pneumoperitoneum. Every 5 minutes for 30 minutes after infusion of lidocaine or magnesium sulfate. Emergence from Anesthesia:
Visual Analog Scale (VAS) for Pain
Time Frame: Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively
Pain intensity assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively
Ramsay Sedation Score
Time Frame: Preoperative (if applicable): Baseline sedation status. Postoperative (PACU): On arrival in PACU: To assess the initial recovery from anesthesia. 30 minutes after arrival in PACU: To evaluate recovery progress and sedation changes. 6 hours postoperat
assess the sedation level in patients recovering from general anesthesia during the postoperative period.The Ramsey Sedation Score is a 6-point scale used to assess the depth of sedation in patients. The score is based on the patient's responsiveness to verbal commands and physical stimuli, which allows clinicians to monitor sedation levels effectively.
Preoperative (if applicable): Baseline sedation status. Postoperative (PACU): On arrival in PACU: To assess the initial recovery from anesthesia. 30 minutes after arrival in PACU: To evaluate recovery progress and sedation changes. 6 hours postoperat
Incidence of Hypotension:
Time Frame: Immediately after induction of anesthesia (post-intubation): Blood pressure (MAP) will be measured to ensure the patient's cardiovascular system is stable after anesthesia induction. After placement in Trendelenburg position (head-down position): Th
A decrease in Mean Arterial Pressure (MAP) by more than 20% from the baseline value
Immediately after induction of anesthesia (post-intubation): Blood pressure (MAP) will be measured to ensure the patient's cardiovascular system is stable after anesthesia induction. After placement in Trendelenburg position (head-down position): Th

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Amira S Kenawy, lecturer, Zagazig University Hospitals, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2026

Primary Completion (Estimated)

July 2, 2026

Study Completion (Estimated)

July 2, 2026

Study Registration Dates

First Submitted

December 6, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB# 1904/2-Nov -2025
  • ethics commitee approval numbe (Other Identifier: zagazig university faculty of medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study is single-center, data contain sensitive patient information, and participant-level access is not planned."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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