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Clinical Trials in China / NCT07193836
Enrolling by invitation Not applicable

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

NCT07193836 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Ningxia Medical University
Phase
Not applicable
Started
2025-09-25
Last updated
2025-09-26

Condition(s) studied

Cholecystectomy, LaparoscopicGynecologic Surgical ProceduresAnesthesia and Procedure Related Time Intervals

Investigational drug(s) / intervention(s)

Normal Saline (0.9% NaCl)Lidocaine →Lidocaine Bolus + Infusion

Normal Saline (0.9% NaCl): Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Ningxia Medical University Yinchuan Ningxia

More General Hospital of Ningxia Medical University trials in China

Propofol vs. Ciprofol for Anesthesia Induction in Frail Elderly Patients Starting soon
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy Starting soon
Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery Enrolling by invitation
Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury Recruiting
Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery Recruiting

Other trials for the same condition

Efficacy and Safety of Cocktail of Ropivacaine for Local Infiltration Analgesia in Patients Undergoing Laparoscopic Cholecystectomy Recruiting
A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07193836 on ClinicalTrials.gov ↗ ← All trials in China