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Enrolling by Invitation

NCT Number: NCT07193836

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal Saline (0.9% NaCl)

Drug

Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia.

Lidocaine

Drug

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

Drug

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.

Primary outcomes

  1. Time to emergence from general anesthesia

    Time frame: Immediately after anesthesia discontinuation (Day 0)

    Measured as the time interval (in seconds) from discontinuation of anesthetics to eye opening on verbal command.

  2. Time to loss of consciousness

    Time frame: 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.

Secondary outcomes

  1. Total propofol dosage during anesthesia induction

    Time frame: During anesthesia induction on Day 0

    Total amount of propofol (in mg) administered from the start of anesthesia to the achievement of loss of consciousness.

  2. Total amount of propofol administered during the entire surgical procedure

    Time frame: During the surgical procedure on Day 0

    Total amount of propofol (in mg/kg/h) administered during the entire surgical procedure

  3. Mean Arterial Pressure (MAP)

    Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)

    MAP will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: mmHg

  4. Heart Rate (HR)

    Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)

    HR will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: beats per minute (bpm)

  5. Oxygen Saturation (SpO₂)

    Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)

    SpO₂ will be recorded at three time points: prior to induction of anesthesia (baseline), during anesthesia maintenance, and after emergence from anesthesia. Unit of Measure: %

  6. Change in Patient State Index (PSI) values at four key timepoints

    Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)

    PSI will be measured using the Masimo SedLine® monitor at:

    Baseline (before induction) After loss of consciousness Minimum value during anesthesia After emergence The difference in PSI between timepoints will be analyzed.

Other outcomes

  1. Incidence of intraoperative hypotension or bradycardia

    Time frame: Intraoperative period (Day 0)

    Number of participants experiencing mean arterial pressure (MAP) <65 mmHg and/or heart rate (HR) <50 bpm requiring pharmacological intervention during surgery.

  2. Incidence of perioperative adverse drug reactions related to propofol or lidocaine

    Time frame: From start of anesthesia induction to 1 hour after emergence (Day 0)

    Adverse drug reactions (ADRs) related to propofol or lidocaine administration will be monitored and recorded during the perioperative period. Specific reactions include, but are not limited to:

    • Hypotension (MAP < 65 mmHg)
    • Bradycardia (HR < 50 bpm)
    • Apnea or respiratory depression
    • Pain on injection
    • Allergic reactions (e.g., rash, pruritus)
    • Delayed emergence from anesthesia
    • Neurological symptoms (e.g., dizziness, perioral numbness)

  3. Postoperative quality of recovery score

    Time frame: Within 24 hours after surgery

    Assessed using a validated quality of recovery questionnaire (e.g., QoR-15 or equivalent), evaluating domains such as physical comfort, emotional state, pain, independence, and support.

  4. Use of doxapram during the emergence phase of anesthesia

    Time frame: From cessation of anesthetic agents to 30 minutes post-emergence (Day 0)

    The number of participants who receive intravenous doxapram during the emergence phase from general anesthesia will be recorded. Doxapram administration is considered if spontaneous breathing or consciousness recovery is delayed beyond clinical expectations. Time of administration, total dose, and reason for use will be documented.

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Acronym: Li

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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