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Colorectal CancerNCT05742438

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

A study testing Lidocaine IV, Dexmedetomidine IV and intrathecal morphine in people with Colorectal Cancer and Anesthesia, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colorectal Cancer, Anesthesia, Cancer Metastatic
What is being tested?
Lidocaine IV, Dexmedetomidine IV and intrathecal morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteSouth Korea
Study dates
12 Apr 2023to 5 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung medical center

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Lidocaine IV, Dexmedetomidine IV, intrathecal morphine
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine IVDrug

    Also called Lidocaine

    Continuous intravenous infusion of lidocaine

  • Dexmedetomidine IVDrug

    Also called Precedex

    Continuous intravenous infusion of dexmedetomidine

  • intrathecal morphineDrug

    Also called Morphine

    intrathecal morphine injection

Study groups in NCT05742438
Study groupRoleWhat they receive
Lidocaine groupActive comparatorA 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.
Receives: Drug: Lidocaine IV
Dexmedetomidine groupActive comparatorA 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.
Receives: Drug: Dexmedetomidine IV
Intrathecal Morphine groupActive comparator200~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.
Receives: Drug: intrathecal morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MMP-9

    plasma Matrix metalloproteinase-9

    Measured: 1 hour after surgery

Secondary outcomes (14)

  1. MMP-9

    plasma Matrix metalloproteinase-9, on the morning of postoperative day 1

    Measured: at the induction of anesthesia

  2. MMP-2

    plasma Matrix metalloproteinase-2

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

  3. IL-6

    Interleukin-6

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

  4. VEGF

    vascular endothelial growth factor

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

  5. lymphocyte subset

    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

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

  6. numeric rating scale

    Pain severity with numeric rating scale for postoperative pain, the value range (0~10), a higher score means more painful

    Measured: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

  7. Opioid consumption

    morphine equivalent unit of opioid consumption

    Measured: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

  8. postoperative nausea/vomiting

    the requirement of rescue antiemetic

    Measured: within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery)

  9. Time to flatus

    from the end of surgery to the time of first flatus

    Measured: within 7 days after the surgery

  10. Hospital length of stay

    from the end of surgery to patient discharge

    Measured: Until the discharge (up to postoperative day 30)

  11. respiratory depression

    pulse oximetry value < 92% or the need for reintubation.

    Measured: during the night of surgery

  12. urinary retention

    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

    Measured: within 7 days after the surgery

  13. Headache and itching sensation

    orthostatic headache and itching sensation

    Measured: within 3 and 1 day after surgery, respectively

  14. reoperation and readmission rate

    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.

    Measured: within 1 month after surgery and discharge, respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start12 Apr 2023
  3. Primary completion5 Jul 2023
  4. Study completion5 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05742438
Sponsor's protocol ID
SMC 2022-10-021-002
Status last verified
Mar 2024
First submitted
6 Feb 2023
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34408981

  • 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.

    PubMed 32616309

  • 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.

    PubMed 31668347

  • 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.

    PubMed 31663690

  • 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.

    PubMed 26441010

  • 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.

    PubMed 30229370

  • Kim J, Lee S, Oh EJ, Park G, Park M. Impact of Intravenous Lidocaine, Dexmedetomidine, and Intrathecal Morphine on Metastasis-Related Biomarkers and Cellular Immune Profiles in Colorectal Surgery: A Prospective, Randomized Controlled Trial. Anesth Analg. 2026 Sep 1;143(3):625-635. doi: 10.1213/ANE.0000000000007978. Epub 2026 Jun 2.

    PubMed 42228944

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine IV, Dexmedetomidine IV and intrathecal morphine in people with Colorectal Cancer and Anesthesia, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MMP-9 (time frame: 1 hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05742438, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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