Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
- Conditions
- Cholecystectomy, LaparoscopicGynecologic Surgical ProceduresAnesthesia and Procedure Related Time Intervals
- Interventions
- Registration Number
- NCT07193836
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 195
- Adults aged 18 to 75 years.
- ASA physical status I-III.
- Scheduled for elective laparoscopic cholecystectomy, laparoscopic
- hysterectomy, or laparoscopic ovarian cystectomy.
- Expected surgical duration < 120 minutes.
- Preoperative normal cognitive function (MoCA > 26).
- Able and willing to provide written informed consent.
- Known allergy to lidocaine or other amide-type local anesthetics.
- History of severe arrhythmias, heart failure (NYHA class III or higher), or epilepsy.
- Central nervous system disorders (e.g., stroke, brain trauma, seizure disorders) or psychiatric illness.
- Severe hepatic or renal dysfunction (ALT/AST > 2× ULN, or eGFR < 60 ml/min/1.73 m²).
- Currently taking medications that affect CNS function (e.g., benzodiazepines, antidepressants, antiepileptics).
- Pregnant or breastfeeding women.
- History of drug or alcohol dependence.
- BMI > 30 kg/m² or < 18 kg/m².
- Inability to understand study procedures or refusal to sign informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Placebo Group Normal Saline (0.9% NaCl) Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period. 2. Lidocaine Bolus Group（Experimental） Lidocaine Participants received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No continuous infusion was administered. 3. Lidocaine Bolus + Infusion Group（Experimental） Lidocaine Bolus + Infusion Participants received an intravenous bolus of lidocaine (1.5 mg/kg) at induction, followed by continuous intravenous infusion of lidocaine (2.0 mg/kg/h) until the end of surgery.
- Primary Outcome Measures
Name Time Method Time to emergence from general anesthesia Immediately after anesthesia discontinuation (Day 0) Measured as the time interval (in seconds) from discontinuation of anesthetics to eye opening on verbal command.
Time to loss of consciousness During anesthesia induction on Day 0 Measured as the time (in seconds) from the beginning of propofol administration to loss of response to verbal command and eyelash reflex.
- Secondary Outcome Measures
Name Time Method Total propofol dosage during anesthesia induction During anesthesia induction on Day 0 Total amount of propofol (in mg) administered from the start of anesthesia to the achievement of loss of consciousness.
Total amount of propofol administered during the entire surgical procedure During the surgical procedure on Day 0 Total amount of propofol (in mg/kg/h) administered during the entire surgical procedure
Mean Arterial Pressure (MAP) Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) 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
Heart Rate (HR) Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) 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)
Oxygen Saturation (SpO₂) Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) 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: %
Change in Patient State Index (PSI) values at four key timepoints Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) 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.
Trial Locations
- Locations (1)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
General Hospital of Ningxia Medical University🇨🇳Yinchuan, Ningxia, China