Cholecystectomy, LaparoscopicLiNCT07193836
Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
A study testing Normal Saline (0.9% NaCl), Lidocaine and Lidocaine Bolus + Infusion in people with Cholecystectomy, Laparoscopic and Gynecologic Surgical Procedures, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This study aims to evaluate the effect of intravenous lidocaine on consciousness changes during anesthesia in patients undergoing laparoscopic cholecystectomy or gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Gynecologic Surgical Procedures, Anesthesia and Procedure Related Time Intervals
- What is being tested?
- Normal Saline (0.9% NaCl), Lidocaine and Lidocaine Bolus + Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
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
- Being tested
- Normal Saline (0.9% NaCl), Lidocaine, Lidocaine Bolus + Infusion
- Keywords
- Lidocaine, General anesthesia, Consciousness, EEG monitoring, PSi index, Anesthesia induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
LidocaineDrug
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 + InfusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Lidocaine Bolus + Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to emergence from general anesthesia
Measured as the time interval (in seconds) from discontinuation of anesthetics to eye opening on verbal command.
Measured: 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.
Measured: During anesthesia induction on Day 0
Secondary outcomes (6)
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.
Measured: During anesthesia induction on Day 0
Total amount of propofol administered during the entire surgical procedure
Total amount of propofol (in mg/kg/h) administered during the entire surgical procedure
Measured: 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
Measured: 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)
Measured: 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: %
Measured: 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.
Measured: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start25 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193836
- Sponsor's protocol ID
- Huiwen Zhang-2025-09
- Acronym
- Li
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Intravenous Lidocaine on Anesthetic Induction and Emergence in Patients Undergoing Laparoscopic Cholecystectomy or Gynecological Surgery
- ClinicalTrials.gov ID
- NCT07193836
- Acronym / sponsor ID
- Li / Huiwen Zhang-2025-09
- Conditions
- Cholecystectomy, Laparoscopic, Gynecologic Surgical Procedures, Anesthesia and Procedure Related Time Intervals
- Keywords
- Lidocaine, General anesthesia, Consciousness, EEG monitoring, PSi index, Anesthesia induction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Placebo Group | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants received an intravenous injection of 0.9% normal saline at induction, with no lidocaine administration throughout the perioperative period. |
| 2. Lidocaine Bolus Group（Experimental） | Experimental | Drug: LidocaineParticipants received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No continuous infusion was administered. |
| 3. Lidocaine Bolus + Infusion Group（Experimental） | Experimental | Drug: Lidocaine Bolus + InfusionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline (0.9% NaCl)Participants in the control group received a single intravenous injection of 0.9% normal saline at induction of anesthesia. | Drug | 1. Placebo Group |
| LidocaineParticipants in this group received a single intravenous bolus of lidocaine (1.5 mg/kg) at anesthesia induction. No additional lidocaine was administered thereafter. | Drug | 2. Lidocaine Bolus Group（Experimental） |
| Lidocaine Bolus + InfusionParticipants 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. | Drug | 3. Lidocaine Bolus + Infusion Group（Experimental） |
Primary outcome
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.
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.
6 secondary outcomes
Total propofol dosage during anesthesia induction
Time frame: During anesthesia induction on Day 0
Total amount of propofol administered during the entire surgical procedure
Time frame: During the surgical procedure on Day 0
Mean Arterial Pressure (MAP)
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Heart Rate (HR)
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Oxygen Saturation (SpO₂)
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Change in Patient State Index (PSI) values at four key timepoints
Time frame: Baseline, intraoperative (Day 0), and immediately post-anesthesia (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline (0.9% NaCl), Lidocaine and Lidocaine Bolus + Infusion in people with Cholecystectomy, Laparoscopic and Gynecologic Surgical Procedures, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to emergence from general anesthesia (time frame: Immediately after anesthesia discontinuation (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.