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

Primary Purpose

Gastric Cancer, Gastrostomy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gastric cancer, laparoscopic gastrectomy, robotic gastrectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A (dexmedetomidine)

Group B (saline)

Arm Description

dexmedetomidine infusion group

normal saline infusion group

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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 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 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 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 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 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.
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.
HOD (hospital days)
To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.

Full Information

First Posted
April 29, 2019
Last Updated
September 24, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03960775
Brief Title
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastrostomy
Keywords
gastric cancer, laparoscopic gastrectomy, robotic gastrectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (dexmedetomidine)
Arm Type
Experimental
Arm Description
dexmedetomidine infusion group
Arm Title
Group B (saline)
Arm Type
Placebo Comparator
Arm Description
normal saline infusion group
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
Saline infusion during same time period.
Primary Outcome Measure Information:
Title
CRP level in blood
Description
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.
Time Frame
Preoperative outpatient 1 day visit
Title
CRP level in blood
Description
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.
Time Frame
Immediately after surgery
Title
CRP level in blood
Description
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.
Time Frame
POD 1 day
Title
CRP level in blood
Description
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.
Time Frame
POD 2 day
Title
CRP level in blood
Description
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.
Time Frame
POD 3 day
Title
CRP level in blood
Description
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.
Time Frame
discharge day (Postoperative day 5)
Title
CRP level in blood
Description
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.
Time Frame
first visit after surgery (POD 1 month)
Secondary Outcome Measure Information:
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
Baseline (Preoperative outpatient visit)
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
immediately after surgery (POD 0)
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
POD 1 day
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
POD 2 day
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
POD 3 day
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
discharge day (Postoperative day 5)
Title
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Description
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.
Time Frame
first visit after surgery (POD 1 month)
Title
WBC level
Description
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.
Time Frame
Baseline (Preoperative outpatient visit)
Title
WBC level
Description
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.
Time Frame
immediately after surgery (POD 0)
Title
WBC level
Description
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.
Time Frame
POD 1 day
Title
WBC level
Description
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.
Time Frame
POD 2 day
Title
WBC level
Description
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.
Time Frame
POD 3 day
Title
WBC level
Description
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.
Time Frame
discharge day (Postoperative day 5)
Title
WBC level
Description
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.
Time Frame
first visit after surgery (POD 1 month)
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
postoperative 0~2hours
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
2~4 hours
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
4~8 hours
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
8~12 hours
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
12~24 hours
Title
postoperative pain score (NRS 0~10)
Description
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.
Time Frame
24~48 hours
Title
postoperative any unwanted admission
Description
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.
Time Frame
postoperative 1 month
Title
gas passing out time
Description
To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.
Time Frame
gas passing time immediately after surgery
Title
HOD (hospital days)
Description
To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.
Time Frame
total days from operation to discharge up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Young Kim, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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