Colorectal cancer
Conditions
Interventions
Control group:Starting from anesthesia induction, intravenous infusion of placebo (normal saline) is administered until the patients return to the ward from the operating room or PACU.
Experimental group (Lidocaine):Starting from anesthesia induction, 2% lidocaine is administered via intravenous infusion (initial dose: 1.5 mg/kg) over 20 minutes
the maintenance dose is 1.5 mg/kg/h (maximum infusion rate: 120 mg/h) and is continued until the patient returns to the ward from the operating room or PACU.
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Aged between 18 and 75 years, inclusive. (2)Body weight between 45 and 100 kg, inclusive. (3)Diagnosis of colon or rectal cancer and scheduled to undergo laparoscopic radical surgery (including robotic-assisted laparoscopic radical surgery). (4)No evidence of distant metastasis. (5)American Society of Anesthesiologists (ASA) physical status classification of I to III. (6)Provision of signed informed consent.
Exclusion criteria
Exclusion criteria: (1)Patients undergoing palliative surgery without curative intent. (2)Patients with known or suspected allergy to lidocaine. (3)Pregnant or lactating patients. (4)Patients at risk of adverse effects from lidocaine accumulation due to intravenous infusion. (5)Patients unable to cooperate with the study due to conditions such as vision/hearing loss, cognitive impairment, or psychiatric disorders. (6)Patients with a history of organ transplantation. (7)Current liver disease, evidenced by any of the following: alanine aminotransferase (ALT) >80 U/L, aspartate aminotransferase (AST) >80 U/L, total bilirubin >44.2 µmol/L (i.e., exceeding twice the upper limit of the laboratory reference range for these parameters), albumin 220 µmol/L for adult males or >180 µmol/L for adult females (i.e., exceeding twice the upper limit of the laboratory reference range). (9)Neurological or psychiatric disorders (including epilepsy). (10)Cardiac diseases: patients with a low cardiac output state due to reduced left ventricular ejection fraction; cardiogenic shock; Adams-Stokes syndrome;Sinus bradycardia with a positive atropine test (sick sinus syndrome), second-degree or higher atrioventricular block, complete left bundle branch block, complete right bundle branch block with left anterior fascicular block, pre-excitation syndrome, or long QT syndrome. (11)Concomitant use of the following medications: antiarrhythmics (e.g., quinidine, amiodarone, propafenone, mexiletine, sotalol); central nervous system depressants (e.g., diazepam, morphine); or the gastric medication cimetidine. (12)Rectal cancer patients who have undergone neoadjuvant chemoradiotherapy. (13)Patients deemed unsuitable for the study by their family, themselves, or the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colorectal cancer patients undergoing laparoscopic radical surgery experienced local and/or metastatic recurrence within three years after the operation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in peripheral blood lymphocyte count and percentage, and levels of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-a) measured preoperatively, on postoperative day 1, and at discharge.;Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery.;Pain scores assessed at 48 hours postoperatively, and at 6 , 12 , 18, 24, 30 and 36 months after discharge.;Recovery of gastrointestinal function on postoperative day 3, as assessed by the GI-3 score.;Incidence of delirium within 3 days after surgery.;Mortality rates at 6, 12, 18, 24,30 and 36 months postoperatively.; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital, Central South University
Outcome results
None listed