Trial no.:	PACTR202305793236698	Date of Approval:	05/05/2023
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Intranasal Dexamedotomidine Vs intranasal Midazolam in pediatric patients undergoing transcatheter ventricular septal defect (VSD) closure

Official scientific title

A comparative study between intranasal dexamedotomidine and intranasal midazolam. Should preoperative sedation be a standard of care in pediatric patients undergoing transcatheter closure of VSD?

Brief summary describing the background and objectives of the trial

In pediatric anaesthesia maternal deprivation is one of the significant challenges that may cause psychological trauma. Preanaesthetic medications with the non-traumatic route of administration decrease anxiety and facilitate the induction of anaesthesia. we aim to compare the sedative effect of intranasal dexamedotomidine and intranasal midazolam in pediatric patients undergoing transcatheter closure of VSD

Type of trial

RCT

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

Disease(s) or condition(s) being studied

Cardiology,Paediatrics

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

Purpose of the trial

Supportive care

Anticipated trial start date

08/04/2023

Actual trial start date

20/04/2023

Anticipated date of last follow up

01/07/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomization using a randomization table created by a computer software program	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Care giver/Provider

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Intranasal dexmedetodine	0.1 μg/kg	20 min before procedure , till child is adequately sedated	medical intervention (preanaesthesia)	30
Control Group	intranasal midazolam	0.2 mg/kg up to 15 mg	20 minutes before induction of anaesthesia	medical intervention	30	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Children of either sex with age ranging from 3 to 12 years old Children with simple congenital heart disease (VSD) undergoing elective cardiac catheterization No coexisting cardiac/medical problems Normal Lab investigations results	Parent refusal Uncooperative patient Allergy to the study drug Any nasal disorder that may interfere with nasal administration of drugs as recurrent nasal bleeding or nasal masses, obstructive pharyngeal or laryngeal pathology Mental retardation.	Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year	3 Year(s)	12 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

20/03/2023

Ain shams university Faculty of medicine Research Ethics Committee FMASUREC

Ethics Committee Address
Street address	City	Postal code	Country
Alabbassia, Cairo	Cairo	11517	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	good sedation , Ramsay scale, child parent separation score	after induction of anaesthesia
Primary Outcome	faster induction of anesthesia	after induction of anaesthesia
Secondary Outcome	maintained hemodynamics	after recovery from anaesthesia
Secondary Outcome	recovery state	after recovery

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Ain shams university	Abbassia street	Cairo		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Yasmin Abdelrazek Esmail	20 ahmed fahim bayoumy, Heliopolis	cairo		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	yasmin abdelrazek	abbassia street	cairo		Egypt	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Yasmin Ali	yasminabdelrazek@med.asu.edu.eg	+201224525233	Ahmed Fahim Bayoumy
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	Associate professor of cardiology
Role	Name	Email	Phone	Street address
Public Enquiries	Sally Hamdy	sallyhamdy44@gmail.com	+201001098885	Abbassia street
City	Postal code	Country	Position/Affiliation
cairo		Egypt	lecturer of anaesthesia
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed shobagy	dr.mohammedelshorbagy@gmail.com	+201227528857	ABBASSIA
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	Associate professor

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Yes, individual participant data will be available. All of the individual participant data collected during the trial, after identification.	Study Protocol	Immediately following publication. No end date.	Data will be available to Researchers who provide a methodologically sound proposal.To achieve aims in the approved proposal. Proposals should be directed to dr.mohammedelshorbagy@gmail.com
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	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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