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

NCT07193836 | Enrolling By Invitation DMC

• 1 other identifier: Huiwen Zhang-2025-09
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Lidocaine; General anesthesia; Consciousness; EEG monitoring; PSi index; Anesthesia induction

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Total propofol dosage during anesthesia induction

  During anesthesia induction on Day 0

• Total amount of propofol administered during the entire surgical procedure

  During the surgical procedure on Day 0

• Mean Arterial Pressure (MAP)

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

• Heart Rate (HR)

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

• Oxygen Saturation (SpO₂)

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

Other Outcomes (4)

• Incidence of intraoperative hypotension or bradycardia

  Intraoperative period (Day 0)

• Incidence of perioperative adverse drug reactions related to propofol or lidocaine

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

• Postoperative quality of recovery score

  Within 24 hours after surgery

Study Arms (3)

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.

Drug: Normal Saline (0.9% NaCl)

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.

Drug: Lidocaine

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.

Drug: Lidocaine Bolus + Infusion

Interventions

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.

1. Placebo Group

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.

2. Lidocaine Bolus Group（Experimental）

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.

3. Lidocaine Bolus + Infusion Group（Experimental）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Saline Solution; Lidocaine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 26, 2025
• Study Start: September 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)