Vecuronium Requirements According to the Operation Phase... | NCT01379352

Studies
Vecuronium Requirements According to the Operation Phase During Liver Transplantation Under Desflurane Anesthesia

NCT01379352

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Dec 25, 2013Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Liver Transplantation

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 22, 2011

First Posted Date

Jun 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2013

Last Update Posted Date

Dec 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

We also postulated that the requirements may be different according to the preoperative hepatic function during preanhepatic phase, and according to the graft to recipient body weight ratio (GRWR) during neohepatic phase.

Therefore, we are trying to investigate the difference of vecuronium requirements according to the phase of surgery, MELD score, GRWR.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High MELD group		Preoperative MELD score greater than 20
Low MELD group		Preoperative MELD score lesser than 20

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing elective living donor liver transplantation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective living donor liver transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gaab Soo Kim, M.D.,Ph.D.	Samsung Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea