Effects of Dexmedetomidine on the Liver Injury After Hepatectomy

Ischemia-reperfusion Injury Clinical Trial

Official title:

the Ethnic Committee of the Chinese People's Liberation Army (PLA) General Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833688
• Other study ID #: PLAGHAOC00***
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2016
• Last updated: January 25, 2017
• Start date: August 2, 2016
• Est. completion date: January 26, 2017

Study information

• Verified date: January 2017
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 26, 2017
• Est. primary completion date: January 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia-reperfusion Injury
• Reperfusion Injury

Intervention

Drug:
• dexmedetomidine
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
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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications after surgery		1 month after surgery
Primary	GST	baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection	24 hours
Secondary	interleukin (IL-6), tumor necrosis factor (TNF-a)	baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy	24 hours