Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lidocaine group 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
Continuous intravenous infusion of lidocaine
Other Names:
|
| Active Comparator: Dexmedetomidine group 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
Continuous intravenous infusion of dexmedetomidine
Other Names:
|
| Active Comparator: Intrathecal Morphine group 150~200mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery. |
Drug: intrathecal morphine
intrathecal morphine injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- MMP [1 day after surgery]
plasma Matrix metalloproteinase-9
- MMP [before surgery]
plasma Matrix metalloproteinase-9
- MMP [1 hour after surgery]
plasma Matrix metalloproteinase-9
Secondary Outcome Measures
- IL-6 [before surgery, 1 hour after surgery, 1 day after surgery]
Interleukin-6
- VEGF [before surgery, 1 hour after surgery, 1 day after surgery]
vascular endothelial growth factor
- lymphocyte subset [before surgery, 1 hour after surgery, 1 day after surgery]
CD3+ T cells, CD4+ helper T cells, CD8+ cytotoxic T cells, natural killer cells
- numeric rating scale [within 3 days after the surgery (0, 1, 6, 24, 48, 72 hour)]
Pain severity with numeric rating scale for postoperative pain, the value range (0~10), a higher score means more painful
- postoperative nausea/vomiting [within 3 days after the surgery (0, 1, 6, 24, 48, 72 hour)]
the requirement of rescue antiemetic
- Opioid consumption [within 3 days after the surgery]
morphine equivalent unit of opioid consumption
- Time to flatus [within 7 days after the surgery]
from the end of surgery to the time of first flatus
- Hospital stay [Until the discharge (up to postoperative day 30)]
from the end of surgery to patient discharge
- Postoperative pulmonary complications [within 7 days after the surgery]
according to the predetermined definition for postoperative pulmonary complications (atelectasis diagnosed by radiographic findings, diagnosed pneumonia)
- postoperative complications [within 1 year 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
- cancer recurrence [within 1 year after the surgery]
local recurrence or distant metastasis
- Mortality [within 1 year after the surgery]
patient survival
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III
Exclusion Criteria:
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Atrioventricular conduction disorder
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Having Bradycardia (<50 bpm)
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Severe pulmonary dysfunction in pulmonary function test
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High risk for cardiovascular complications(expected postoperative event >5%)
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Allergy or hypersensitivity reaction to each adjuvant.
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History or risk factors for Malignant hyperthermia
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Body mass index >40 kg/m2
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Samsung Medical Center
- Korea Institute of Science and Technology
Investigators
- Study Director: Mihye Park, MD, PhD, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Galos EV, Tat TF, Popa R, Efrimescu CI, Finnerty D, Buggy DJ, Ionescu DC, Mihu CM. Neutrophil extracellular trapping and angiogenesis biomarkers after intravenous or inhalation anaesthesia with or without intravenous lidocaine for breast cancer surgery: a prospective, randomised trial. Br J Anaesth. 2020 Nov;125(5):712-721. doi: 10.1016/j.bja.2020.05.003. Epub 2020 Jun 29.
- Le-Wendling L, Nin O, Capdevila X. Cancer Recurrence and Regional Anesthesia: The Theories, the Data, and the Future in Outcomes. Pain Med. 2016 Apr;17(4):756-75. doi: 10.1111/pme.12893. Epub 2016 Feb 2.
- Liu Y, Sun J, Wu T, Lu X, Du Y, Duan H, Yu W, Su D, Lu J, Tian J. Effects of serum from breast cancer surgery patients receiving perioperative dexmedetomidine on breast cancer cell malignancy: A prospective randomized controlled trial. Cancer Med. 2019 Dec;8(18):7603-7612. doi: 10.1002/cam4.2654. Epub 2019 Oct 30.
- Wall TP, Buggy DJ. Perioperative Intravenous Lidocaine and Metastatic Cancer Recurrence - A Narrative Review. Front Oncol. 2021 Aug 2;11:688896. doi: 10.3389/fonc.2021.688896. eCollection 2021.
- Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
- SMC 2022-10-021-002