Clinical trial NCT03960775: The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
Official title: The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy; Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Gastrostomy
Keywords: gastric cancer
laparoscopic gastrectomy
robotic gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: * 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

Eligibility criteria: 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

Primary outcomes:
measure: CRP level in blood
timeFrame: Preoperative outpatient 1 day visit
measure: CRP level in blood
timeFrame: Immediately after surgery
measure: CRP level in blood
timeFrame: POD 1 day
measure: CRP level in blood
timeFrame: POD 2 day
measure: CRP level in blood
timeFrame: POD 3 day
measure: CRP level in blood
timeFrame: discharge day (Postoperative day 5)
measure: CRP level in blood
timeFrame: first visit after surgery (POD 1 month)
Secondary outcomes:
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: Baseline (Preoperative outpatient visit)
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: immediately after surgery (POD 0)
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: POD 1 day
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: POD 2 day
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: POD 3 day
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: discharge day (Postoperative day 5)
measure: cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
timeFrame: first visit after surgery (POD 1 month)
measure: WBC level
timeFrame: Baseline (Preoperative outpatient visit)
measure: WBC level
timeFrame: immediately after surgery (POD 0)
measure: WBC level
timeFrame: POD 1 day
measure: WBC level
timeFrame: POD 2 day
measure: WBC level
timeFrame: POD 3 day
measure: WBC level
timeFrame: discharge day (Postoperative day 5)
measure: WBC level
timeFrame: first visit after surgery (POD 1 month)
measure: postoperative pain score (NRS 0~10)
timeFrame: postoperative 0~2hours
measure: postoperative pain score (NRS 0~10)
timeFrame: 2~4 hours
measure: postoperative pain score (NRS 0~10)
timeFrame: 4~8 hours
measure: postoperative pain score (NRS 0~10)
timeFrame: 8~12 hours
measure: postoperative pain score (NRS 0~10)
timeFrame: 12~24 hours
measure: postoperative pain score (NRS 0~10)
timeFrame: 24~48 hours
measure: postoperative any unwanted admission
timeFrame: postoperative 1 month
measure: gas passing out time
timeFrame: gas passing time immediately after surgery
measure: HOD (hospital days)
timeFrame: total days from operation to discharge up to 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
affiliation: Severance Hospital
name: Na Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: