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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-08-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Anesthesia Cancer Metastatic Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine group

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.

Group Type ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type DRUG

Continuous intravenous infusion of lidocaine

Dexmedetomidine group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine IV

Intervention Type DRUG

Continuous intravenous infusion of dexmedetomidine

Intrathecal Morphine group

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

Group Type ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type DRUG

intrathecal morphine injection

Interventions

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Lidocaine IV

Continuous intravenous infusion of lidocaine

Intervention Type DRUG

Dexmedetomidine IV

Continuous intravenous infusion of dexmedetomidine

Intervention Type DRUG

intrathecal morphine

intrathecal morphine injection

Intervention Type DRUG

Other Intervention Names

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Lidocaine Precedex Morphine

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No