Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
NCT ID: NCT07193836
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
195 participants
INTERVENTIONAL
2025-09-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1. Placebo Group
Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period.
Normal Saline (0.9% NaCl)
Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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General Hospital of Ningxia Medical University
OTHER
Responsible Party
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Locations
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General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Countries
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Other Identifiers
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Huiwen Zhang-2025-09
Identifier Type: -
Identifier Source: org_study_id
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