Sugammadex Reversal of Neuromuscular Blockade and Postope... | NCT02939430

Studies
Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding

NCT02939430

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Feb 7, 2017Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Blood Coagulation Tests ( INR, APTT)

Interventions

Sugammadex intravenous
Intravenous neostigmine and atropine

Countries

Egypt

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Oct 17, 2016

First Submission Date that Met QC Criteria

Oct 19, 2016

First Posted Date

Oct 20, 2016Estimated

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

Feb 5, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Reversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg)	Drug: Intravenous neostigmine and atropine
Sugammadex group	Experimental	Reversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg	Drug: Sugammadex intravenous

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex intravenous	Drug	Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation	Sugammadex group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
activated partial thromboplastin tile in seconds		30 min

Secondary Outcomes

Measure	Description	Time Frame
international normalized ratio in second		30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all candidates for living donor liver transplantation

Exclusion Criteria:

massive intraoperative bleeding manifestations of early graft dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university	Recruiting	Al Mansurah	Dkahleya		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001285	Atropine

Ancestor Terms

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided