The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable gastric-cancer
Started Apr 2019
Shorter than P25 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedStudy Start
First participant enrolled
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2019
CompletedSeptember 28, 2020
September 1, 2020
7 months
April 29, 2019
September 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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)
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 Outcomes (23)
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
Baseline (Preoperative outpatient visit)
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
immediately after surgery (POD 0)
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
POD 1 day
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
POD 2 day
cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level
POD 3 day
- +18 more secondary outcomes
Study Arms (2)
Group A (dexmedetomidine)
EXPERIMENTALdexmedetomidine infusion group
Group B (saline)
PLACEBO COMPARATORnormal saline infusion group
Interventions
Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
Eligibility Criteria
You may qualify if:
- \. 20-70 yrs old patients
- \. Scheduled for robot or laparoscopic gastrectomy
- \. Body weight under 90kg and BMI under 32
You may not qualify if:
- \. Emergency operation
- \. Reoperation
- \. Co-operation with other surgery department
- \. Co-operation with other organs (except cholecystectomy)
- \. Patients with history of heart failure (unstable angina, congestive heart failure)
- \. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
- \. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg), extremely bradycardia (HR \<45 bpm on ECG)
- \. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia
- \. Patients who is steroid user
- \. Patients who is beta blocker user
- \. Patients with history of liver failure, renal failure, allergic to medicine
- \. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
- \. Patients who cannot read the consent form (examples: Illiterate, foreigner)
- \. Patients who withdraw the consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Na Young Kim, MD
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 23, 2019
Study Start
April 30, 2019
Primary Completion
November 29, 2019
Study Completion
November 29, 2019
Last Updated
September 28, 2020
Record last verified: 2020-09