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

Not Applicable

Completed

• Conditions: Gastric Cancer; Gastrostomy
• Interventions: Drug: dexmedetomidine; Drug: saline

• Registration Number: NCT03960775
• Lead Sponsor: Yonsei University

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

Study Timeline

• Study First Submitted: 2019-04-29
• Study Start: 2019-04-30
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1. 20-70 yrs old patients
• 2. Scheduled for robot or laparoscopic gastrectomy
• 3. Body weight under 90kg and BMI under 32

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (dexmedetomidine)	dexmedetomidine	dexmedetomidine infusion group
Group B (saline)	saline	normal saline infusion group

Primary Outcome Measures

Name	Time	Method
CRP level in blood	first visit after surgery (POD 1 month)	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.

Secondary Outcome Measures

Name	Time	Method
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level	first visit after surgery (POD 1 month)	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.
WBC level	first visit after surgery (POD 1 month)	To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.
postoperative pain score (NRS 0~10)	24~48 hours	To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.
postoperative any unwanted admission	postoperative 1 month	To evaluate the effect of dexmedetomidine on postoperative any unwanted admission in patients undergoing robot or laparoscopic gastrectomy, postoperative any unwanted admission was checked during postoperative 1 month.
gas passing out time	gas passing time immediately after surgery	To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.
HOD (hospital days)	total days from operation to discharge up to 2 weeks	To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of