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

ConditionsInfertility FemaleHemodynamic Instability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-40
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Lidocaine (drug)

    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.

  • 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.

Treatment groups

69 Participants
are divided into 3 treatment groups
Group A: Arm 1: Control Group (Normal Saline)Placebo comparator 1 intervention
Group B: Arm 2: Lidocaine GroupExperimental treatment 1 intervention
Group C: Arm 3: Magnesium Sulfate GroupExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

heart rate

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.

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:
2

Visual Analog Scale (VAS) for Pain

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.

Time frame
Visual Analog Scale (VAS) for Pain 30 minutes, 2 hours, and 6 hours postoperatively
3

Ramsay Sedation Score

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.

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
4

Incidence of Hypotension:

A decrease in Mean Arterial Pressure (MAP) by more than 20% from the baseline value

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: