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NCT Number: NCT02833688

Effects of Dexmedetomidine on the Liver Injury After Hepatectomy

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.

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Key information

Conditions

Ischemia-Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

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 outcomes

  1. GST

    Time frame: 24 hours

    baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection

Secondary outcomes

  1. interleukin (IL-6), tumor necrosis factor (TNF-a)

    Time frame: 24 hours

    baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy

Other outcomes

  1. Complications after surgery

    Time frame: 1 month after surgery

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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