Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201411000912262 Date of Approval: 19/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sugammadex versus neostigmine for antagonism of rocuronium-induced neuromuscular blockade in cirrhotic patients undergoing liver resection
Official scientific title Sugammadex versus neostigmine for antagonism of rocuronium-induced neuromuscular blockade in cirrhotic patients undergoing liver resection: A controlled randomised study
Brief summary describing the background and objectives of the trial Liver resection is a major lengthy operation that has major effects on patient haemodynamics and perioperative liver functions . Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics . Rocuronium is an intermediate acting steroidal non-depolarizing neuromuscular blocker that is mostly metabolized by the liver. Its onset time is longer in cirrhotic patients than in those with normal liver function. To speed up the process of antagonism of residual neuromuscular blockade, inhibitors of acetyl cholinesterases such as neostigmine are usually administered only when there is evidence of spontaneous recovery of neuromuscular function. Too early administration of neostigmine is not effective and may produce serious side-effects . Sugammadex, a modified ¿-cyclodextrin, is the first selective relaxant binding agent. It forms very tight, stable complexes we will try to evaluate the use of it neostigmine for antagonism of rocuronium-induced neuromuscular blockade in cirrhotic patients undergoing liver resection: A controlled randomised study
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Cirrhotic patients after liver resection,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 31/10/2014
Actual trial start date 31/10/2014
Anticipated date of last follow up 28/02/2015
Actual Last follow-up date 28/02/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sugammadex / Liver cirrhosis 2 mg/kg At the end 2 mg/kg Sugammadex at the end of operation 15
Experimental Group Neostigmine / Liver cirrhosis 50 µg/kg At the end Neostigmine 50 µg/kg combined with atropine 20 µg/kg 15
Control Group Sugammadex/ Normal liver 2 mg/kg At the end 2 mg/kg Sugammadex at the end of operation 15 Active-Treatment of Control Group
Control Group Neostigmine / Normal liver 50 µg/kg At the end Neostigmine 50 µg/kg combined with atropine 20 µg/kg 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists physical status class I-III (Class I in patients with preoperative normal liver functions). Thirty patients categorized as Child classification ¿A¿ with a Model for End-Stage Liver Disease (MELD) score <10. Additional 30 patients with normal preoperative liver functions will serve as controls Co-existing neuromuscular disease, body mass index more than 35 kg/m-2, renal impairment, medications known to affect neuromuscular transmission e.g. aminoglycoside antibiotics or magnesium sulphate, bleeding tendency, and intraoperative events e.g. (massive bleeding and hypothermia). 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Menoufyia University, National Liver Institute (NLI), IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street Shebeen El.koom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time from the start of sugammadex or neostigmine administration to recovery of the TOF ratio to 0.9 At the end of the surgery 15 minutes after achieving a train-of-four ratio 1, 2, 4, 6, 8, 12, 18, and 24 h after administration of sugammadex or neostigmine
Secondary Outcome Duration of anaesthesia and surgery. End of surgery
Secondary Outcome Total dose of rocuronium. Total duration of the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassin abd elghafar street Shebeen El.koom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Yassen Yassin abd elghafar street Shebeen El.koom Egypt
Maha lotfy El Sheikh Yassin abd elghafar street Shebeen El.koom Egypt
Mohamed Abdulatif Mohamed Faculty of Medicine, Cairo University Cairo Egypt
Mohamed Helmy Afifi Faculty of Medicine, Menofeyia University Menofeyia Egypt
Mahmoud Gamal Mousa Yassin abd elghafar street Shebeen El.koom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled yassen kyassen61@hotmail.com 002-010-63080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Maha Lotfy mahalotfy37@yahoo.com 002-0482221729 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
REPORTING
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