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出境医 / 临床实验 / The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy
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 | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 84 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Double 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 : | April 30, 2019 |
| Actual Primary Completion Date : | November 29, 2019 |
| Actual Study Completion Date : | November 29, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group A (dexmedetomidine)
dexmedetomidine infusion group
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Drug: dexmedetomidine
Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
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Placebo Comparator: Group B (saline)
normal saline infusion group
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Drug: saline
Saline infusion during same time period.
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Outcome Measures
Primary Outcome Measures :
- CRP level in blood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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
| Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | |
| Seoul, Korea, Republic of, 03722 | |
Sponsors and Collaborators
Yonsei University
Investigators
| Principal Investigator: | Na Young Kim, MD | Severance Hospital |
| Tracking Information | |||||
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| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 23, 2019 | ||||
| Last Update Posted Date | September 28, 2020 | ||||
| Actual Study Start Date ICMJE | April 30, 2019 | ||||
| Actual Primary Completion Date | November 29, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy | ||||
| Official Title ICMJE | 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 | ||||
| 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
84 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | November 29, 2019 | ||||
| Actual Primary Completion Date | November 29, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03960775 | ||||
| Other Study ID Numbers ICMJE | 4-2019-0055 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Yonsei University | ||||
| Study Sponsor ICMJE | Yonsei University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Yonsei University | ||||
| Verification Date | September 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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