Anesthesia, Cancer Metastatic, Colorectal Cancer, Inflammation
Conditions
Brief summary
This is a prospective randomized controlled trial. Investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis. Patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. And we will compare the clinical outcomes in the three method.
Detailed description
Perioperative period is critical in determining the risk of postoperative metastatic disease. Surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. Increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery. Also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. However, no comparison was conducted among these anesthetic adjuvants. Thus, Investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.
Interventions
DRUGLidocaine IV
Continuous intravenous infusion of lidocaine
Continuous intravenous infusion of dexmedetomidine
DRUGintrathecal morphine
intrathecal morphine injection
Sponsors
Korea Institute of Science and Technology
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III
Exclusion criteria
* Atrioventricular conduction disorder * Having Bradycardia (\<50 bpm) * Severe pulmonary dysfunction in pulmonary function test * High risk for cardiovascular complications(expected postoperative event \>5%) * Allergy or hypersensitivity reaction to each adjuvant. * History or risk factors for Malignant hyperthermia * Body mass index \>40 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MMP-9 | 1 hour after surgery | plasma Matrix metalloproteinase-9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MMP-2 | at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery | plasma Matrix metalloproteinase-2 |
| IL-6 | at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery | Interleukin-6 |
| VEGF | at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery | vascular endothelial growth factor |
| lymphocyte subset | at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery | CD3+CD4+ (helper T cells), CD3+CD8+ (cytotoxic T cells), CD3-CD16+CD56+ (Natural killer(NK) cells), CD3+CD16+CD56+ NK T cell, CD39+, CD73+, CD39+CD73+ expressions on CD4+ and CD8+ T cells |
| numeric rating scale | within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery) | Pain severity with numeric rating scale for postoperative pain, the value range (0\ 10), a higher score means more painful |
| Opioid consumption | within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery) | morphine equivalent unit of opioid consumption |
| MMP-9 | at the induction of anesthesia | plasma Matrix metalloproteinase-9, on the morning of postoperative day 1 |
| Time to flatus | within 7 days after the surgery | from the end of surgery to the time of first flatus |
| Hospital length of stay | Until the discharge (up to postoperative day 30) | from the end of surgery to patient discharge |
| respiratory depression | during the night of surgery | pulse oximetry value \< 92% or the need for reintubation. |
| urinary retention | within 7 days after the surgery | need for in-and-out catheterization or reinsertion of an indwelling urinary catheter during the hospital stay after the original urinary catheter was removed, and re-operation |
| Headache and itching sensation | within 3 and 1 day after surgery, respectively | orthostatic headache and itching sensation |
| reoperation and readmission rate | within 1 month after surgery and discharge, respectively | Reoperation was defined as any surgical procedure performed under general or regional anaesthesia for treatment of complications related to the initial operation within 30 days after surgery. Readmission was defined as any hospital admission occurring after discharge within 30 days from the index surgery, specifically related to postoperative complications or management associated with the initial surgical procedure. |
| postoperative nausea/vomiting | within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery) | the requirement of rescue antiemetic |
Countries
South Korea
Outcome results
None listed