This study aims to evaluate the effect of intravenous lidocaine on consciousness changes during anesthesia in patients undergoing laparoscopic cholecystectomy or gynecologic surgery. A total of 150 patients will be randomly assigned to one of three groups: a single-dose lidocaine group, a continuous-infusion group, or a placebo group. All patients will receive standard anesthesia care, and the study will monitor brain activity using EEG-based PSi values to measure anesthesia induction time, recovery time, and changes in consciousness. The goal is to determine whether lidocaine can reduce the amount of anesthetic used, shorten the time to fall asleep, and promote faster awakening after surgery. The results may help improve anesthesia safety and enhance recovery in surgical patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia.
Participants in this group received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No additional lidocaine was administered thereafter.
Participants in this group received a bolus of lidocaine (1.5 mg/kg) at induction followed by continuous intravenous infusion of lidocaine (2 mg/kg/h) until the end of surgery.
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Time to emergence from general anesthesia
Measured as the time interval (in seconds) from discontinuation of anesthetics to eye opening on verbal command.
Time frame: Immediately after anesthesia discontinuation (Day 0)
Time to loss of consciousness
Measured as the time (in seconds) from the beginning of propofol administration to loss of response to verbal command and eyelash reflex.
Time frame: During anesthesia induction on Day 0
Total propofol dosage during anesthesia induction
Total amount of propofol (in mg) administered from the start of anesthesia to the achievement of loss of consciousness.
Time frame: During anesthesia induction on Day 0
Total amount of propofol administered during the entire surgical procedure
Total amount of propofol (in mg/kg/h) administered during the entire surgical procedure
Time frame: During the surgical procedure on Day 0
Mean Arterial Pressure (MAP)
MAP will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: mmHg
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Heart Rate (HR)
HR will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: beats per minute (bpm)
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Oxygen Saturation (SpO₂)
SpO₂ will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: %
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Change in Patient State Index (PSI) values at four key timepoints
PSI will be measured using the Masimo SedLine® monitor at: Baseline (before induction) After loss of consciousness Minimum value during anesthesia After emergence The difference in PSI between timepoints will be analyzed.
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
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