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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960775
• Other study ID #: 4-2019-0055
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastrostomy
• Inflammation
• Stomach Neoplasms

Intervention

Drug:
• dexmedetomidine
Dexmedetomidine infusion (0.4?/kg/hr) from anesthetic induction until the start of closure of peritoneum.
• saline
Saline infusion during same time period.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative outpatient 1 day visit
Primary	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.	Immediately after surgery
Primary	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.	POD 1 day
Primary	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.	POD 2 day
Primary	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.	POD 3 day
Primary	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.	discharge day (Postoperative day 5)
Primary	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.	first visit after surgery (POD 1 month)
Secondary	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.	Baseline (Preoperative outpatient visit)
Secondary	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.	immediately after surgery (POD 0)
Secondary	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.	POD 1 day
Secondary	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.	POD 2 day
Secondary	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.	POD 3 day
Secondary	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.	discharge day (Postoperative day 5)
Secondary	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.	first visit after surgery (POD 1 month)
Secondary	WBC level	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.	Baseline (Preoperative outpatient visit)
Secondary	WBC level	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.	immediately after surgery (POD 0)
Secondary	WBC level	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.	POD 1 day
Secondary	WBC level	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.	POD 2 day
Secondary	WBC level	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.	POD 3 day
Secondary	WBC level	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.	discharge day (Postoperative day 5)
Secondary	WBC level	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.	first visit after surgery (POD 1 month)
Secondary	postoperative pain score (NRS 0~10)	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 0~2hours
Secondary	postoperative pain score (NRS 0~10)	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.	2~4 hours
Secondary	postoperative pain score (NRS 0~10)	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.	4~8 hours
Secondary	postoperative pain score (NRS 0~10)	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.	8~12 hours
Secondary	postoperative pain score (NRS 0~10)	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.	12~24 hours
Secondary	postoperative pain score (NRS 0~10)	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.	24~48 hours
Secondary	postoperative any unwanted admission	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.	postoperative 1 month
Secondary	gas passing out time	To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.	gas passing time immediately after surgery
Secondary	HOD (hospital days)	To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.	total days from operation to discharge up to 2 weeks