An interventional study of Lidocaine IV and Dexmedetomidine IV in Colorectal Cancer, Anesthesia and Cancer Metastatic, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 114 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
A loading dose of 1.5mg/kg lidocaine will be infused for 10 minutes during anesthesia induction. During the surgery and post-anaesthesia care unit (PACU) stay, 1.5 mg/kg/h of lidocaine were continuously infused until the patient was transferred to the general ward.
Drug: Lidocaine IV
A loading dose of 0.3mcg/kg dexmedetomidine will be infused for 10 minutes during anesthesia induction. During the surgery and PACU stay, 0.3 mcg/kg/h of dexmedetomidine were continuously infused until the patient was transferred to the general ward.
Drug: Dexmedetomidine IV
200\~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.
Drug: intrathecal morphine
Continuous intravenous infusion of lidocaine
Also known as: Lidocaine
Continuous intravenous infusion of dexmedetomidine
Also known as: Precedex
intrathecal morphine injection
Also known as: Morphine
MMP-9
plasma Matrix metalloproteinase-9
Time frame: 1 hour after surgery
MMP-9
plasma Matrix metalloproteinase-9, on the morning of postoperative day 1
Time frame: at the induction of anesthesia
MMP-2
plasma Matrix metalloproteinase-2
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
IL-6
Interleukin-6
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
VEGF
vascular endothelial growth factor
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
lymphocyte subset
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
Time frame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
numeric rating scale
Pain severity with numeric rating scale for postoperative pain, the value range (0\~10), a higher score means more painful
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
Opioid consumption
morphine equivalent unit of opioid consumption
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
postoperative nausea/vomiting
the requirement of rescue antiemetic
Time frame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
Time to flatus
from the end of surgery to the time of first flatus
Time frame: within 7 days after the surgery
Hospital length of stay
from the end of surgery to patient discharge
Time frame: Until the discharge (up to postoperative day 30)
respiratory depression
pulse oximetry value \< 92% or the need for reintubation.
Time frame: during the night of surgery
urinary retention
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
Time frame: within 7 days after the surgery
Headache and itching sensation
orthostatic headache and itching sensation
Time frame: within 3 and 1 day after surgery, respectively
reoperation and readmission rate
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.
Time frame: within 1 month after surgery and discharge, respectively
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center