Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery

General Hospital of Ningxia Medical University

Status: Invitation-only

Conditions: Gynecologic Surgical Procedures; Cholecystectomy, Laparoscopic; Anesthesia and Procedure Related Time Intervals

Treatments: Drug: Normal Saline (0.9% NaCl); Drug: Lidocaine Bolus + Infusion; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07193836

Huiwen Zhang-2025-09

Details and patient eligibility

About

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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 3 patient groups, including a placebo group

1. Placebo Group

Placebo Comparator group

Description:

Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period.

Treatment:

Drug: Normal Saline (0.9% NaCl)

2. Lidocaine Bolus Group（Experimental）

Experimental group

Description:

Participants received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No continuous infusion was administered.

Treatment:

Drug: Lidocaine

3. Lidocaine Bolus + Infusion Group（Experimental）

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine Bolus + Infusion