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Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding (Suga_bleeding)

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ClinicalTrials.gov Identifier: NCT02939430
Recruitment Status : Unknown
Verified February 2017 by AlRefaey Kandeel, Mansoura University.
Recruitment status was:  Recruiting
First Posted : October 20, 2016
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Study Start Date : November 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. activated partial thromboplastin tile in seconds [ Time Frame: 30 min ]

Secondary Outcome Measures :
  1. international normalized ratio in second [ Time Frame: 30 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all candidates for living donor liver transplantation

Exclusion Criteria:

  • massive intraoperative bleeding manifestations of early graft dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939430


Locations
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Egypt
Mansoura university Recruiting
Mansoura, Dkahleya, Egypt
Contact: Alreafey Kandeel, MD    00201008158591    refa3ey2@yahoo.com   
Gastroenterology center Recruiting
Mansoura, Egypt, 35516
Contact: Amr M Yassen, professor       amryassen@hotmail.com   
Sponsors and Collaborators
Mansoura University

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Responsible Party: AlRefaey Kandeel, lecturer of anesthesia, Mansoura University
ClinicalTrials.gov Identifier: NCT02939430     History of Changes
Other Study ID Numbers: Refa-suga-bleeding
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Atropine
Neostigmine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics