NCT01379352

Brief Summary

The vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. The requirements may also be different according to the preoperative hepatic function as measured by MELD score during prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase. Therefore, the investigators are trying to investigate the difference of vecuronium requirements according to the phase of surgery or MELD score, GRWR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

June 21, 2011

Last Update Submit

December 24, 2013

Conditions

Keywords

liver transplantationvecuronium

Outcome Measures

Primary Outcomes (3)

  • vecuronium requirements during preanhepatic phase

    total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during preanhepatic phase

    during prehepatic phase of liver transplantation

  • vecuronium requirements during anhepatic phase

    total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during anhepatic phase

    during anhepatic phase of liver transplantation

  • vecuronium requirements during neohepatic phase

    total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during neohepatic phase

    during neohepatic phase of liver transplantation

Study Arms (2)

High MELD group

Preoperative MELD score greater than 20

Low MELD group

Preoperative MELD score lesser than 20

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective living donor liver transplantation

You may qualify if:

  • patients undergoing elective living donor liver transplantation

You may not qualify if:

  • patients who can not undergo train-of-four test due to central or peripheral neuromuscular disease.
  • patients with severe cardiopulmonary diseases.
  • patients who received transfusion with more than 10 units of packed red blood cells.
  • primary non-functioning graft immediately after reperfusion of the graft.
  • patients who administered drugs that influences the metabolism of vecuronium (such as anticonvulsant: phenytoin, carbamazepine, primidone, sodium valproate)
  • patients undergoing cadaver donor liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

  • Gaab Soo Kim, M.D.,Ph.D.

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations