Trial no.:	PACTR201907522427588	Date of Approval:	05/07/2019
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Sugammadex versus neostigmine for antagonism of rocuronium-induced neuromuscular blockade in infants with biliary atresia undergoing kasai operation . A randomized control trial

Official scientific title

Sugammadex versus neostigmine for antagonism of rocuronium-induced neuromuscular blockade in infants with biliary atresia undergoing kasai operation: A randomized control trial

Brief summary describing the background and objectives of the trial

Biliary atresia is characterized by a progressive inflammatory process affecting portal tracts, inflammatory cell proliferation, and bile duct obstruction and proliferation, thus results in biliary cirrhosis and liver function failure. The incidence is 1 in 18,000 live births, during the neonatal period. Hepatoportoenterostomy (Kasai operation) remains the main line of treatment to relief biliary obstruction in these infants. Despite these efforts about 50% of children who received kasai operation will need liver transplantation. Rocuronium is an intermediate acting steroidal non-depolarizing neuromuscular blocker that is mostly metabolized by the liver . Although elimination kinetics are unchanged in patients with cirrhosis, rocuronium recovery time is prolonged in cirrhotic patients .Sugammadex, a modified γ-cyclodextrin, is the first selective relaxant binding agent. It forms very tight, stable complexes in a 1:1 ratio with rocuronium. The inactive sugammadex-rocuronium complex undergoes renal elimination. Sugammadex has no effect on acetylcholinesterases or on any receptor system in the body, eliminating the need for anticholinergic drugs. Sugammadex can antagonize any level of neuromuscular blockade, including the profound blockade induced by rocuronium .It is of clinical relevance to note that in the presence of sugammadex, the hepatic biotransformation and final clearance of rocuronium via biliary excretion is changed to a completely differ¬ent (liver-independent) renal pathway . This randomised controlled clinical trial is designed to compare the pharmacodynamic profiles of sugammadex and neostigmine when used for the antagonism of moderate degree of rocuronium-induced neuromuscular block in this age group with impaired liver function.

Type of trial

CCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

01/04/2019

Actual trial start date

01/04/2019

Anticipated date of last follow up

30/12/2019

Actual Last follow-up date

30/12/2019

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

Recruitment status

Active, not recruiting

Publication URL

00157/2019

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 randomization	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Neostigmine	Neostigmine 50 ug/kg combined with atropine 20 g/kg.	once	At the end of surgery and when two responses to train-of-four ulnar nerve stimulation are detected (T2), patients will be receive neostigmine 50ug/kg combined with atropine 20ug/kg. Patients will continue to receive low concentration of sevoflurane until adequate recovery of neuromuscular transmission and to ensure reliable monitoring and recording of the progressive recovery of TOF ratio. Neuromuscular transmission monitoring will be continued 15 minutes after achieving a train-of-four ratio of 1.0 to ensure sustained neuromuscular recovery and absence or occurrence of re-curarization.	20	Active-Treatment of Control Group
Experimental Group	Sugammadex	Sugammadex 2mg/kg.	once	At the end of surgery and when two responses to train-of-four ulnar nerve stimulation are detected (T2), patients will be receive sugammadex (Bridion, Organon, Netherlands) 2 mg/kg .Patients will continue to receive low concentration of sevoflurane until adequate recovery of neuromuscular transmission and to ensure reliable monitoring and recording of the progressive recovery of TOF ratio. Neuromuscular transmission monitoring will be continued 15 minutes after achieving a train-of-four ratio of 1.0 to ensure sustained neuromuscular recovery and absence or occurrence of re-curarization.	20

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
- infants aged below 3 months undergoing kasai operation. - American Society of Anesthesiologists physical status class I-II	- Co-existing known or suspected neuromuscular disease, 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).	Infant: 0 Month(s)-12 Month(s)	2 Month(s)	3 Month(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

01/03/2019

INSTITUTION REVIEW BOARD OF THE NATIONAL LIVER INSTITUTE MENOUFIA UNIVERSITY

Ethics Committee Address
Street address	City	Postal code	Country
YASSIN ABDEL GHAFAR	menofia	048123	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 train of four (TOF ratio to 0.9.)	second
Secondary Outcome	- Duration of anaesthesia and surgery	hours

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
national liver institute	yassin abdelghafar street	menoufia	0481234	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
eman sayed	abdallah street	giza	1234	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	National liver institute	yassin abdel ghafar	menofia	048123	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Eman Sayed	national liver institute menofeya university	sheben el kom menofeya	048123	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	eman sayed	emansayed825@gmail.com	002701282271464	5 abdelah esmaeil nasser elthawara
City	Postal code	Country	Position/Affiliation
giza	048123	Egypt	MD
Role	Name	Email	Phone	Street address
Public Enquiries	GASSER ELAZAB	g-elazb@l.ver.menofia.edu.eg	01289663992	menofeya
City	Postal code	Country	Position/Affiliation
shebin elkom	048123	Egypt	MD
Role	Name	Email	Phone	Street address
Scientific Enquiries	HESHAM MAGED	heshammaged@yahoo.com	002701223548537	FESAL
City	Postal code	Country	Position/Affiliation
GIZA	1234	Egypt	MD

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	we will share individual participant data through the PubMed	Study Protocol	we will share individual participant data through any journal cited at the PubMed	we will use SPSS program for statistical analysis for both descriptive and analytic of the data
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
pubmed	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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