The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy

Yonsei University84 enrolled

Overview

Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.

* Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr * Control group (normal saline group) Continuous IV normal saline using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Gastric Cancer Gastrostomy

Interventions

dexmedetomidineDRUG

Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.

salineDRUG

Saline infusion during same time period.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. 20-70 yrs old patients * 2\. Scheduled for robot or laparoscopic gastrectomy * 3\. Body weight under 90kg and BMI under 32 Exclusion Criteria: * 1\. Emergency operation * 2\. Reoperation * 3\. Co-operation with other surgery department * 4\. Co-operation with other organs (except cholecystectomy) * 5\. Patients with history of heart failure (unstable angina, congestive heart failure) * 6\. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem * 7\. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg), extremely bradycardia (HR \<45 bpm on ECG) * 8\. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia * 9\. Patients who is steroid user * 10\. Patients who is beta blocker user * 11\. Patients with history of liver failure, renal failure, allergic to medicine * 12\. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression) * 13\. Patients who cannot read the consent form (examples: Illiterate, foreigner) * 14\. Patients who withdraw the consent

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: Preoperative outpatient 1 day visit

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: Immediately after surgery

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: POD 1 day

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: POD 2 day

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: POD 3 day

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: discharge day (Postoperative day 5)

CRP level in blood

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

Time frame: first visit after surgery (POD 1 month)

Secondary Outcomes

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

Time frame: Baseline (Preoperative outpatient visit)

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: immediately after surgery (POD 0)

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: POD 1 day

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: POD 2 day

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: POD 3 day

cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: discharge day (Postoperative day 5)

Data from ClinicalTrials.gov

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cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level

Time frame: first visit after surgery (POD 1 month)

WBC level