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

NCT05742438 | Completed

• 1 other identifier: SMC 2022-10-021-002
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Anesthesia; Cancer Metastatic; Inflammation

Outcome Measures

Primary Outcomes (1)

• MMP-9

  plasma Matrix metalloproteinase-9

  1 hour after surgery

Secondary Outcomes (14)

• MMP-9

  at the induction of anesthesia

• MMP-2

  at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

• IL-6

  at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

• VEGF

  at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

• lymphocyte subset

  at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery

Study Arms (3)

Lidocaine group

ACTIVE COMPARATOR

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

Dexmedetomidine group

ACTIVE COMPARATOR

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

Intrathecal Morphine group

ACTIVE COMPARATOR

200\~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.

Drug: intrathecal morphine

Interventions

Lidocaine IV DRUG

Continuous intravenous infusion of lidocaine

Also known as: Lidocaine

Lidocaine group

Dexmedetomidine IV DRUG

Continuous intravenous infusion of dexmedetomidine

Also known as: Precedex

Dexmedetomidine group

intrathecal morphine DRUG

intrathecal morphine injection

Also known as: Morphine

Intrathecal Morphine group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korea Institute of Science and Technology: collaborator

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

Related Publications (6)

• 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.

  PMID: 30229370 BACKGROUND

• 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.

  PMID: 34408981 BACKGROUND

• 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.

  PMID: 32616309 BACKGROUND

• 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.

  PMID: 31668347 BACKGROUND

• 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.

  PMID: 31663690 BACKGROUND

• 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.

  PMID: 26441010 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Inflammation

Interventions

Lidocaine; Dexmedetomidine; Morphine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mihye Park, MD, PhD

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 24, 2023
• Study Start: April 12, 2023
• Primary Completion: July 5, 2023
• Study Completion: August 5, 2023
• Last Updated: April 2, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)