Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery

Colorectal Cancer Clinical Trial

Official title:

Effect of Dexmedetomidine Infusion, Lidocaine Infusion, and Intrathecal Morphine Injection on Biomarker for Perioperative Stress and Immune Response, and Cancer Progression and Metastasis in Colorectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742438
• Other study ID #: SMC 2022-10-021-002
• Status: Completed
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: August 5, 2023

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cancer Metastatic
• Colorectal Cancer
• Colorectal Neoplasms
• Inflammation

Intervention

Drug:
• Lidocaine IV
Continuous intravenous infusion of lidocaine
• Dexmedetomidine IV
Continuous intravenous infusion of dexmedetomidine
• intrathecal morphine
intrathecal morphine injection

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korea Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

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. — View Citation

Levins KJ, Prendeville S, Conlon S, Buggy DJ. The effect of anesthetic technique on micro-opioid receptor expression and immune cell infiltration in breast cancer. J Anesth. 2018 Dec;32(6):792-796. doi: 10.1007/s00540-018-2554-0. Epub 2018 Sep 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMP	plasma Matrix metalloproteinase-9	1 day after surgery
Primary	MMP	plasma Matrix metalloproteinase-9	before surgery
Primary	MMP	plasma Matrix metalloproteinase-9	1 hour after surgery
Secondary	MMP	plasma Matrix metalloproteinase-2	before surgery, 1 hour after surgery, 1 day after surgery
Secondary	IL-6	Interleukin-6	before surgery, 1 hour after surgery, 1 day after surgery
Secondary	VEGF	vascular endothelial growth factor	before surgery, 1 hour after surgery, 1 day after surgery
Secondary	lymphocyte subset	CD3+CD4+ (inducer and helper T cells), CD3+CD8+ (suppressor and cytotoxic T cells), CD3-CD16+CD56+ (Natural killer cells), CD39+CD73+ (circulating regulatory T cells), CD73+CD8+ T cells, CD73+CD4+ T cells	before surgery, 1 hour after surgery, 1 day after surgery
Secondary	numeric rating scale	Pain severity with numeric rating scale for postoperative pain, the value range (0~10), a higher score means more painful	within 3 days after the surgery (0, 1, 6, 24, 48, 72 hour)
Secondary	postoperative nausea/vomiting	the requirement of rescue antiemetic	within 3 days after the surgery (0, 1, 6, 24, 48, 72 hour)
Secondary	Opioid consumption	morphine equivalent unit of opioid consumption	within 3 days after the surgery
Secondary	Time to flatus	from the end of surgery to the time of first flatus	within 7 days after the surgery
Secondary	Hospital stay	from the end of surgery to patient discharge	Until the discharge (up to postoperative day 30)
Secondary	Postoperative pulmonary complications	according to the predetermined definition for postoperative pulmonary complications (atelectasis diagnosed by radiographic findings, diagnosed pneumonia)	within 7 days after the surgery
Secondary	postoperative complications	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	within 1 year after the surgery
Secondary	cancer recurrence	local recurrence or distant metastasis	within 1 year after the surgery
Secondary	Mortality	patient survival	within 1 year after the surgery