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

NCT07359560 | Not Yet Recruiting

• 2 other identifiers: ZU-IRB# 1904/2-Nov -2025ethics commitee approval numbe
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility Female; Hemodynamic Instability

Keywords

lidocaine magnisium; hemodynamic instability; infertility female; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• the mean arterial pressure

  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 Outcomes (4)

• heart rate

  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

  Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively

• Ramsay Sedation Score

  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:

  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

Study Arms (3)

Arm 1: Control Group (Normal Saline)

PLACEBO COMPARATOR

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)

Arm 2: Lidocaine Group

EXPERIMENTAL

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)

Arm 3: Magnesium Sulfate Group

EXPERIMENTAL

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

Interventions

Lidocaine (drug) 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.

Also known as: magnisium sulfate, saline

Arm 2: Lidocaine Group

magnesium sulfate DRUG

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.

Arm 3: Magnesium Sulfate Group

Normal Saline (Intravenous) DRUG

0.9% normal saline, total volume 15 mL, administered intravenously over 15 minutes starting 30 minutes before the anticipated time of extubation.

Arm 1: Control Group (Normal Saline)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: The full title of the study is "Intravenous Lidocaine Versus Magnesium Sulfate for Hemodynamic Stability During Emergence From General Anesthesia in Infertility-Related Laparoscopic Gynecologic surgeries" , and the inclusion criteria focus on conditions and procedures unique to women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Medicine

Zagazig, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride; Saline Solution; Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Amira S Kenawy, lecturer

  Zagazig University Hospitals, Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira S principal investigator, lecturer

CONTACT

01092014663; IRB_123@medicine.zu.edu.eg

Amira S Kenawy, lecturer

CONTACT

01092014663; amira9981@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug preparations (lidocaine, magnesium sulfate, and normal saline) will be prepared in identical syringes and infusion bags by an anesthesiologist who is not involved in patient care or data collection. This ensures that participants, anesthesia care providers, investigators, and outcome assessors remain blinded to group allocation throughout the study. Randomization codes will be securely stored and will not be revealed until after data analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Intensive Care, and Pain Management

Model Details: Participants will be randomly allocated into three parallel groups to receive one of the study interventions (intravenous lidocaine, intravenous magnesium sulfate, or normal saline control). Each participant will receive only one intervention, and outcomes will be assessed independently for each group. Randomization and identical preparation of study drugs will maintain blinding of participants, anesthesia providers, and outcome assessors throughout the study.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: January 22, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)