Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Time to emergence from general anesthesia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study uses a quadruple-blind design. Participants, care providers, investigators, and outcome assessors were blinded to group allocation to minimize performance and assessment bias.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1. Placebo Group
Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period.
干预措施: Normal Saline (0.9% NaCl) (Drug)
2. Lidocaine Bolus Group（Experimental）
Participants received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No continuous infusion was administered.
干预措施: Lidocaine (Drug)
3. Lidocaine Bolus + Infusion Group（Experimental）
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.
干预措施: Lidocaine Bolus + Infusion (Drug)
结局指标
主要结局
Time to emergence from general anesthesia
时间窗: 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
时间窗: 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.
次要结局
- Total propofol dosage during anesthesia induction(During anesthesia induction on Day 0)
- Total amount of propofol administered during the entire surgical procedure(During the surgical procedure on Day 0)
- Mean Arterial Pressure (MAP)(Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0))
- Heart Rate (HR)(Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0))
- Oxygen Saturation (SpO₂)(Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0))
- Change in Patient State Index (PSI) values at four key timepoints(Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0))