Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery
- Conditions
- Colorectal CancerCancer MetastaticAnesthesiaInflammation
- Interventions
- Registration Number
- NCT05742438
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine group Dexmedetomidine 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. Lidocaine group Lidocaine IV 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. Intrathecal Morphine group intrathecal morphine 200\~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.
- Primary Outcome Measures
Name Time Method MMP-9 1 hour after surgery plasma Matrix metalloproteinase-9
- Secondary Outcome Measures
Name Time Method MMP-9 at the induction of anesthesia plasma Matrix metalloproteinase-9, on the morning of postoperative day 1
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
postoperative nausea/vomiting within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery) the requirement of rescue antiemetic
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.
Trial Locations
- Locations (1)
Samsung medical center
🇰🇷Seoul, Korea, Republic of