Clinical trial NCT05742438: Effects of Dexmedetomidine/Lidocaine/Intrathecal Morphine on Cancer Metastasis Biomarker After Colorectal Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Anesthesia
Cancer Metastatic
Inflammation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Institute of Science and Technology
First posted: 2023-02-24
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: MMP-9
timeFrame: 1 hour after surgery
Secondary outcomes:
measure: MMP-9
timeFrame: at the induction of anesthesia
measure: MMP-2
timeFrame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
measure: IL-6
timeFrame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
measure: VEGF
timeFrame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
measure: lymphocyte subset
timeFrame: at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery
measure: numeric rating scale
timeFrame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
measure: Opioid consumption
timeFrame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
measure: postoperative nausea/vomiting
timeFrame: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)
measure: Time to flatus
timeFrame: within 7 days after the surgery
measure: Hospital length of stay
timeFrame: Until the discharge (up to postoperative day 30)
measure: respiratory depression
timeFrame: during the night of surgery
measure: urinary retention
timeFrame: within 7 days after the surgery
measure: Headache and itching sensation
timeFrame: within 3 and 1 day after surgery, respectively
measure: reoperation and readmission rate
timeFrame: within 1 month after surgery and discharge, respectively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Mihye Park, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.
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.
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.