Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Und… (NCT07193836) | Clinical Trial Compass
By InvitationNot Applicable
Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
China195 participantsStarted 2025-09-25
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to emergence from general anesthesia
Timeframe: Immediately after anesthesia discontinuation (Day 0)
2
Time to loss of consciousness
Timeframe: During anesthesia induction on Day 0
Trial details
NCT IDNCT07193836
SponsorGeneral Hospital of Ningxia Medical University