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.: PACTR201511001296403 Date of Registration: 06/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study between sugammadex and neostigmine
Official scientific title Comparative study between sugammadex and neostigmine for the reversal of neuromuscular block in pediatric patients undergoing lower abdominal surgeries.
Brief summary describing the background and objectives of the trial Muscle relaxants are routinely used worldwide as a part of a modern concept of balanced anesthesia. They can be categorized as depolarizing (eg, succinylcholine) and nondepolarizing (steroid-based and benzylisoquinoline) muscle relaxants. Although nondepolarizing muscle relax¬ants have very few adverse effects (mostly allergic reactions) during anesthesia, a residual duration of action of muscle relaxants beyond the end of the operation, also referred to as postoperative residual curarization (PORC), is a well-known problem. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and selective one. Today, sugammadex is an alternative to the decurarization procedure, which was traditionally executed with cholinesterase inhibitors. PORC and the muscarinic side effects are not anticipated when using sugammadex, which has been developed so as to be selective for rocuronium and vecuronium. Sugammadex is a modified gammacyclodextrin, developed as a reversal agent for steroidal neuromuscular blocking drugs. It forms a tight one-to-one complex with rocuronium (or vecuronium), encapsulating the drug in the plasma and hence reducing its concentration at the neuromuscular junction and rapidly reversing the block. The aim of this work is to compare sugammadex and neostigmine in the reversal of neuromuscular block in pediatric patients undergoing lower abdominal surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied neuromuscular blockade,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 12/10/2015
Actual trial start date 12/10/2015
Anticipated date of last follow up 02/05/2016
Actual Last follow-up date
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 Simple randomization using a randomisation table created by a computer software program An independent statistician will be assigned to perform central randomization to ensure proper concealment of the study management from patients and investigators until the release of the final statistical results. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sugammadex group initial dose of sugammadex 2mg/kg however if TOF ratio won¿t reach 0.9 within 3 minute another dose of sugammadex [2mg/kg] will be given. when post- tetanic count is 1 to 2 our patient will receive initial dose of sugammadex 2mg/kg however if TOF ratio won¿t reach 0.9 within 3 minute another dose of sugammadex [2mg/kg] will be given. 30
Experimental Group neostagmine group 0.3 mg/kg neostagmine plus 0.01mg/kg atropine will be given only when T2 reappear on TOF 0.3 mg/kg neostagmine plus 0.01mg/kg atropine will be given only when T2 reappear on TOF (< 90% of nicotinic receptors are blocked). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists (ASA) class I or II pediatric patients aged 2-10 years undergoing lower abdominal surgeries. Body mass index more than 40 kg/m2, liver or kidney disease, history of malignant hyperthermia, neuromuscular disease, history of hypersensitivity to any of the study drugs and mental retardation. 2 Year(s) 10 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 Faculty of medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to reach TOF ratio greater than 0.90 wil be recorded Time to reach TOF ratio greater than 0.90 will be recorded
Primary Outcome Number of patients needing another dose of sugammadex to reach TOF greater than 0.90 Number of patients requiring additional sugammadex dose to reach TOF greater than 0.90
Primary Outcome Extubation time PACU discharge time (min) time form admission till modified Aldrete scale greater or equal to 9
Secondary Outcome Adverse events Adverse events (post-operative nausea and vomiting (PONV), shivering, bradycardia, dry mouth and respitatory depression(defind as a respiratory rate less than 8 or oxygen saturation less than 90%)
Secondary Outcome Body temperature Body temperature will be recorded every five minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya University Hospital 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
amany s ammar 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
khaled m mahmoud 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201223436409 2Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201223436409 2Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201223436409 2Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University
REPORTING
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