NCT02833688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

August 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

July 5, 2016

Last Update Submit

January 25, 2017

Conditions

Ischemia-reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • GST

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

    24 hours

Secondary Outcomes (1)

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

    24 hours

Other Outcomes (1)

  • Complications after surgery

    1 month after surgery

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

0.9% sodium chloride

PLACEBO COMPARATOR

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

Interventions

dexmedetomidineDRUG

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.

dexmedetomidine
0.9% sodium chlorideDRUG

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.

0.9% sodium chloride

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) I\~III
  • selected to have hepatectomy in our hospital, Child-Pugh A
  • patient's consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Weidong MI, Doctor

    CHINA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 14, 2016

Study Start

August 2, 2016

Primary Completion

January 26, 2017

Study Completion

January 26, 2017

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

CN(1)