Effects of Dexmedetomidine on the Liver Injury After Hepatectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemia-reperfusion Injury
• Intervention / Treatment: Drug: dexmedetomidine; Drug: 0.9% sodium chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GST	baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interleukin (IL-6), tumor necrosis factor (TNF-a)	baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy	24 hours

Other Outcome Measures

Outcome Measure	Time Frame
Complications after surgery	1 month after surgery

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: Weidong MI, Doctor, China

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2016
• Primary Completion (Actual): January 26, 2017
• Study Completion (Actual): January 26, 2017

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: PLAGHAOC00***

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED