Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline (0.9% NaCl), Lidocaine, Lidocaine Bolus + Infusion.
- Who it may be relevant to
- Registry conditions: Cholecystectomy, Laparoscopic, Gynecologic Surgical Procedures, Anesthesia and Procedure Related Time Intervals. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Normal Saline (0.9% NaCl)
Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia. - Drug Lidocaine
Participants in this group received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No additional lidocaine was administered thereafter. - Drug Lidocaine Bolus + Infusion
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.
Primary outcome measures
- Time to emergence from general anesthesia [Time frame: Immediately after anesthesia discontinuation (Day 0)]
- Time to loss of consciousness [Time frame: During anesthesia induction on Day 0]
Secondary outcome measures (6)
- Total propofol dosage during anesthesia induction [Time frame: During anesthesia induction on Day 0]
- Total amount of propofol administered during the entire surgical procedure [Time frame: During the surgical procedure on Day 0]
- Mean Arterial Pressure (MAP) [Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)]
- Heart Rate (HR) [Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)]
- Oxygen Saturation (SpO₂) [Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)]
- Change in Patient State Index (PSI) values at four key timepoints [Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- General Hospital of Ningxia Medical University — Yinchuan
Identifiers
NCT: NCT07193836 · Huiwen Zhang-2025-09