Gastric Cancer, Gastrostomy
Conditions
Keywords
gastric cancer, laparoscopic gastrectomy, robotic gastrectomy
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
Interventions
DRUGdexmedetomidine
Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
DRUGsaline
Saline infusion during same time period.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP level in blood | Preoperative outpatient 1 day visit | 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
| Measure | Time frame | Description |
|---|---|---|
| WBC level | Baseline (Preoperative outpatient visit) | 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) | postoperative 0~2hours | 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. |
| cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level | Baseline (Preoperative outpatient visit) | 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed