Suga_bleeding: Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02939430

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Coagulation Tests ( INR, APTT)	Drug: Sugammadex intravenous Drug: Intravenous neostigmine and atropine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Reversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg)	Drug: Intravenous neostigmine and atropine
Experimental: Sugammadex group Reversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg	Drug: Sugammadex intravenous Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation

Arm

Intervention/Treatment

Active Comparator: Control

Reversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg)

Drug: Intravenous neostigmine and atropine

Experimental: Sugammadex group

Reversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg

Drug: Sugammadex intravenous

Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation

Outcome Measures

Primary Outcome Measures

activated partial thromboplastin tile in seconds [30 min]

Secondary Outcome Measures

international normalized ratio in second [30 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all candidates for living donor liver transplantation

Exclusion Criteria:

massive intraoperative bleeding manifestations of early graft dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university	Mansoura	Dkahleya	Egypt
2	Gastroenterology center	Mansoura		Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AlRefaey Kandeel, lecturer of anesthesia, Mansoura University

ClinicalTrials.gov Identifier:

NCT02939430

Other Study ID Numbers:

Refa-suga-bleeding

First Posted:

Oct 20, 2016

Last Update Posted:

Feb 7, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Atropine

Neostigmine

Study Results

No Results Posted as of Feb 7, 2017