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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• the mean arterial pressure [Срок оценки: 6 months]

Вторичные конечные точки (4)

• heart rate [Срок оценки: 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 [Срок оценки: Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively]
• Ramsay Sedation Score [Срок оценки: 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: [Срок оценки: 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]

Критерии участия

Критерии включения

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

Критерии исключения

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Zagazig University Faculty of Medicine — Zagazig

Идентификаторы

NCT: NCT07359560 · ZU-IRB# 1904/2-Nov -2025 · ethics commitee approval numbe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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