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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03960775

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastrostomy	Drug: dexmedetomidine Drug: saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind randomized controlled trialDouble blind randomized controlled trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Apr 30, 2019

Actual Primary Completion Date :

Nov 29, 2019

Actual Study Completion Date :

Nov 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (dexmedetomidine) dexmedetomidine infusion group	Drug: dexmedetomidine Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
Placebo Comparator: Group B (saline) normal saline infusion group	Drug: saline Saline infusion during same time period.

Arm

Intervention/Treatment

Experimental: Group A (dexmedetomidine)

dexmedetomidine infusion group

Drug: dexmedetomidine

Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.

Placebo Comparator: Group B (saline)

normal saline infusion group

Drug: saline

Saline infusion during same time period.

Outcome Measures

Primary Outcome Measures

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.
CRP level in blood [Immediately after surgery]
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.
CRP level in blood [POD 1 day]
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.
CRP level in blood [POD 2 day]
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.
CRP level in blood [POD 3 day]
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.
CRP level in blood [discharge day (Postoperative day 5)]
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.
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

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.
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [immediately after surgery (POD 0)]
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.
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [POD 1 day]
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.
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [POD 2 day]
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.
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [POD 3 day]
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.
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level [discharge day (Postoperative day 5)]
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.
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 [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.
WBC level [immediately after surgery (POD 0)]
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.
WBC level [POD 1 day]
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.
WBC level [POD 2 day]
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.
WBC level [POD 3 day]
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.
WBC level [discharge day (Postoperative day 5)]
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.
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) [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.
postoperative pain score (NRS 0~10) [2~4 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 pain score (NRS 0~10) [4~8 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 pain score (NRS 0~10) [8~12 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 pain score (NRS 0~10) [12~24 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

1. Emergency operation
1. Reoperation
1. Co-operation with other surgery department
1. Co-operation with other organs (except cholecystectomy)
1. Patients with history of heart failure (unstable angina, congestive heart failure)
1. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
1. Patients with history of uncontrolled hypertension (diastolic BP >110mmHg), extremely bradycardia (HR <45 bpm on ECG)
1. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia
1. Patients who is steroid user
1. Patients who is beta blocker user
1. Patients with history of liver failure, renal failure, allergic to medicine
1. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
1. Patients who cannot read the consent form (examples: Illiterate, foreigner)
1. Patients who withdraw the consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul		Korea, Republic of	03722