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

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Samsung Medical Center

Status

Completed

Conditions

Inflammation
Cancer Metastatic
Anesthesia
Colorectal Cancer

Treatments

Drug: intrathecal morphine
Drug: Dexmedetomidine IV
Drug: Lidocaine IV

Study type

Interventional

Funder types

Other

Identifiers

NCT05742438
SMC 2022-10-021-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

114 participants in 3 patient groups

Lidocaine group
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine IV
Dexmedetomidine group
Active Comparator group
Description:
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.
Treatment:
Drug: Dexmedetomidine IV
Intrathecal Morphine group
Active Comparator group
Description:
200\~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.
Treatment:
Drug: intrathecal morphine

Trial contacts and locations

1

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Central trial contact

Jeayoun Kim, MD

Data sourced from clinicaltrials.gov

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