Effects of Dexmedetomidine on the Liver Injury After Hepatectomy
Primary Purpose
Ischemia-reperfusion Injury
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
0.9% sodium chloride
Sponsored by
About this trial
This is an interventional prevention trial for Ischemia-reperfusion Injury
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I~III
- selected to have hepatectomy in our hospital, Child-Pugh A
- patient's consent
Exclusion Criteria:
- refusing to attend or attending in other clinical study
- having severe cardio-pulmonary disease, ejection fraction (EF)<40%, having cardiac infarction in recent three months, chronic obstructive pulmonary disease (COPD) (PaO2<60mmHg)
- pregnant or lactating women
- having neuropsychiatric disorders
- emergent surgeries,hemorrhage shock,
- rupture and hemorrhage of liver tumor
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexmedetomidine
0.9% sodium chloride
Arm Description
dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Outcomes
Primary Outcome Measures
GST
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection
Secondary Outcome Measures
interleukin (IL-6), tumor necrosis factor (TNF-a)
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy
Full Information
NCT ID
NCT02833688
First Posted
July 5, 2016
Last Updated
January 25, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02833688
Brief Title
Effects of Dexmedetomidine on the Liver Injury After Hepatectomy
Official Title
the Ethnic Committee of the Chinese People's Liberation Army (PLA) General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
January 26, 2017 (Actual)
Study Completion Date
January 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle maneuver. A few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion (IR) injury caused by the secretion of reactive oxygen species and inflammatory cytokines. Glutathione-S-transferase (GST) was a sensitive and specific marker for hepatic injury in several studies before. So the investigator decided to use it as the primary endpoint. Besides, in our center, there are some liver resection surgeries that didn't need occlusion. So it can serve the best placebo for determine the the actual effect of dexmedetomidine on the IR injury in further subgroup analysis.
Detailed Description
The purpose of our study is to compare liver injury with dexmedetomidine. The enrolled patients were randomized into two group. In the study group, dexmedetomidine, diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. While, 0.9% sodium chloride serves as the placebo with the same loading dose and infusion rate in the control group. The infusion is ceased after the resection of the hepatic issues.
GST is a sensitive and specific marker for hepatic injury in several studies before and is taken as the primary endpoint. And the investigator use other inflammatory cytokines reflecting the systemic inflammatory response in serum. Besides these, the investigator observe the hemodynamic changes during the operation time and complications related with anesthesia and surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-reperfusion Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Arm Title
0.9% sodium chloride
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Intervention Description
0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
Primary Outcome Measure Information:
Title
GST
Description
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
interleukin (IL-6), tumor necrosis factor (TNF-a)
Description
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Complications after surgery
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) I~III
selected to have hepatectomy in our hospital, Child-Pugh A
patient's consent
Exclusion Criteria:
refusing to attend or attending in other clinical study
having severe cardio-pulmonary disease, ejection fraction (EF)<40%, having cardiac infarction in recent three months, chronic obstructive pulmonary disease (COPD) (PaO2<60mmHg)
pregnant or lactating women
having neuropsychiatric disorders
emergent surgeries,hemorrhage shock,
rupture and hemorrhage of liver tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong MI, Doctor
Organizational Affiliation
CHINA
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Dexmedetomidine on the Liver Injury After Hepatectomy
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