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.: PACTR202008761557201 Date of Approval: 13/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title sedation for diagnostic trans-esophageal echocardiography in pediatrics
Official scientific title Feasibility of procedural sedation for diagnostic trans-esophageal echocardiography in pediatric patients
Brief summary describing the background and objectives of the trial During transesophageal echocardiography (TEE)‑guided procedure, general anesthesia (GA) with endotracheal intubation is preferred to protect airway with TEE probe in situ which is uncomfortable and has to be tolerated by the patient for a prolonged period. However, GA is associated with a stress response, delayed recovery, and decreased patient turnover in catheterization laboratory. Conscious sedation can overcome these drawbacks.Delivery of pediatric sedation and anesthesia outside of the OR is an example of a high-risk, low error-tolerance setting for anesthesia services.Dexmedetomidine is a central α2 receptor agonist .Over time; this drug has gained popularity for use in the pediatric The aim of this study is to evaluate the feasibility of procedural sedation with propofol-dexmedetomidine for diagnostic trans-esophageal echocardiography in paediatric.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
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 Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anesthesia intravenous propofol 2 mg/kg or sevoflurane inhalational induction according to cooperation of the child during the whole procedure patients will receive general anesthesia with propofol 2 mg/kg, rocuronium 0.9 mg/kg and Fentanyl 2 mcg/kg or induction with sevoflurane in uncooperative children then tracheal intubation will be done. Anesthesia will be maintained by sevoflurane 1-2% in oxygen, rocuronium bromide 0.3 mg/kg will be given as required. 30 Placebo
Experimental Group sedation sedation with Fentanyl 2 mcg/kg and dexmedetomidine 1 μg/kg and propofol 1.5 mg/kg intravenous bolus over 10 minutes then an infusion of dexmedetomidine 0.3 μg/kg/h and propofol 25 to 100 mcg/kg/min for maintenance during the whole procedure patients will receive sedation with Fentanyl 2 mcg/kg and dexmedetomidine 1 μg/kg and propofol 1.5 mg/kg intravenous bolus over 10 minutes then an infusion of dexmedetomidine 0.3 μg/kg/h and propofol 25 to 100 mcg/kg/min for maintenance and local lidocaine (10%) spray until the loss of a triggered gag reflex by a tongue depressor.Oxygen supplementation by nasal cannula (3-4 l/min). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 3-7 years old, ASA II and III, eligible for diagnostic transesophageal echocardiography (TEE) parent's refusal, neurological , psychiatric disorders,or mental retardation, those with risk of aspiration, allergy or contraindication to dexmedetomidine or propofol, those requiring TEE or general anesthesia for another reason than diagnostic TEE (e.g. interventional cardiac catheterization, heart surgery and intubated child in intensive care). Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 7 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 01/08/2019 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome recovery time start from end of anesthesia or sedation till discharge from OR
Secondary Outcome Hemodynamic parameters (HR and MBP) baseline, after intubation in group I and at the end of bolus dose of the infused drugs in group II, every 5 min till the end of the procedure, then every 30
Secondary Outcome time to reach appropriate level of anesthesia or sedation Time elapsed from induction until introduction of TEE probe
Secondary Outcome Success rate of introduction of TEE probe at first time at the beginning of the procedure
Secondary Outcome physician's satisfaction at the end of the procedure
Secondary Outcome Adverse effects during and after 2 hours of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of Medicine Elgeish St Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mona Raafat Elghamry Elgeish St Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
Atteia Gad Anwar Elgeish st Tanta 31527 Egypt
Mohamed Ahmed Lotfy Elgeish St Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atteia Anwar atteiagad@gmail.com +201025547544 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Lotfy Dr.mohamed_lotfy@hotmail.com +201222444184 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of recovery time, hemodynamic parameters, time needed for anesthesia or sedation, sucess rate of TEE probe insertion at first time, physician's satisfaction, and adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for scientific research purpose only up on e-mail request with reason of the request. request will be sent to e-mail (drmonagh19802000@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