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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Placebo Group | Placebo Comparator | Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period. |
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| 2. Lidocaine Bolus Group（Experimental） | Experimental | Participants received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No continuous infusion was administered. |
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| 3. Lidocaine Bolus + Infusion Group（Experimental） | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to emergence from general anesthesia | Measured as the time interval (in seconds) from discontinuation of anesthetics to eye opening on verbal command. | Immediately after anesthesia discontinuation (Day 0) |
| Time to loss of consciousness | Measured as the time (in seconds) from the beginning of propofol administration to loss of response to verbal command and eyelash reflex. | During anesthesia induction on Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Total propofol dosage during anesthesia induction | Total amount of propofol (in mg) administered from the start of anesthesia to the achievement of loss of consciousness. | During anesthesia induction on Day 0 |
| Total amount of propofol administered during the entire surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative hypotension or bradycardia | Number of participants experiencing mean arterial pressure (MAP) <65 mmHg and/or heart rate (HR) <50 bpm requiring pharmacological intervention during surgery. | Intraoperative period (Day 0) |
| Incidence of perioperative adverse drug reactions related to propofol or lidocaine |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
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This study uses a quadruple-blind design. Participants, care providers, investigators, and outcome assessors were blinded to group allocation to minimize performance and assessment bias.
| 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. |
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| 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. |
|
Total amount of propofol (in mg/kg/h) administered during the entire surgical procedure |
| During the surgical procedure on Day 0 |
| Mean Arterial Pressure (MAP) | 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 | Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) |
| Heart Rate (HR) | 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) | Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) |
| Oxygen Saturation (SpO₂) | 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: % | Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0) |
| Change in Patient State Index (PSI) values at four key timepoints | 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. | Baseline, intraoperative (Day 0), and immediately post-anesthesia (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:
|
| From start of anesthesia induction to 1 hour after emergence (Day 0) |
| Postoperative quality of recovery score | 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. | Within 24 hours after surgery |
| Use of doxapram during the emergence phase of anesthesia | 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. | From cessation of anesthetic agents to 30 minutes post-emergence (Day 0) |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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