The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial

Study Overview
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Brief Summary
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Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to HIPEC is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. This study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.

Official Title
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The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients between 20 and 70 years old obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery weights under 90 kg and BMI under 32 Exclusion Criteria: emergency operation re-operations combined surgery over 4 departments. cardiac disease (unstable angina, congestive heart failure, valvular heart disease) Ventricular conduction abnormality prior pacemaker insertion uncontrolled hypertension (diastolic blood pressure > 110mmHg) bradycardia (HR < 40 Bpm) cerebral vascular disease (cerebral hemorrhage, cerebral ischemia) hepatic or renal failure patients who take antiarrythmic agent neurological or psychiatric illnesses foreigner and patient who can not read the letter

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine infusion group<br> | Drug: dexmedetomidine<br>* Group A: dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. Group B: Saline infusion during same time period.<br>|
| Active Comparator: normal saline infusion group<br> | Drug: Normal saline<br>* Group B: Saline infusion during same time period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 level | To evaluate the effect of dexmedetomidine on the level of IL-6 in patient undergoing HIPEC, IL-6 level was measured up to 12 hours after surgery. | Up to 12 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected. | up to 1 year after surgery |