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

Yonsei University

Status: Completed

Conditions: Gastric Cancer; Gastrostomy

Treatments: Drug: dexmedetomidine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03960775

4-2019-0055

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

84 participants in 2 patient groups, including a placebo group

Group A (dexmedetomidine)

Experimental group

Description:

dexmedetomidine infusion group

Treatment:

Drug: dexmedetomidine

Group B (saline)

Placebo Comparator group

Description:

normal saline infusion group

Treatment:

Drug: saline