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.: PACTR202308786657562 Date of Approval: 03/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Caffeine for fast-track surgery and cognitive functions in children undergoing open heart surgery: a randomized, double-blind, controlled study.
Official scientific title Caffeine for fast-track pediatric cardiac anesthesia in children undergoing open heart surgeries: a randomized, double-blind, controlled study.
Brief summary describing the background and objectives of the trial Fast tracking after repair of congenital heart defects (CHD) is a process involving the reduction of perioperative period by timely admission, early extubation after surgery, short intensive care unit (ICU) stay, early mobilization, and faster hospital discharge. Fast track anesthesia is feasible and safe and reduces the occurrence of ventilator induced complications, thereby decreasing ICU stay, resource use and cost .Emergence delirium (ED) is a behavioral disturbance in children, which is characterized by crying, thrashing, inconsolability, and disorientation in the early postanesthetic period. It is reported that the incidence of ED in children anesthetized with sevoflu¬rane is up to 80%, much higher than that in adults .Clinically, caffeine is used to treat neonatal apnea and certain types of headaches. Caffeine acts by a variety of mechanisms including inhibiting phosphodiesterase to elevate intracellular cAMP, as well as antagonizing adenosine receptors A1 and A2A. Blockade of the A2A receptor subtype has been shown to mediate caffeine’s arousal effects . In infants, Caffeine has now largely replaced theophylline and aminophylline for treatment of apnea of prematurity in infants because of its wider therapeutic index and longer half-life that allows once daily administration . This prospective, controlled, randomized study will be conducted to evaluate the effect of Caffeine for the fast track pediatric cardiac anesthesia in children undergoing open heart surgery via median sternotomy. We hypothesize that intravenous caffeine would enhance fast track anesthesia and reduce the time to e
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 06/08/2023
Actual trial start date
Anticipated date of last follow up 01/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group caffeine group will receive an IV infusion of caffeine citrate at 20 mg/kg (maximum 200 mg) over10 minutes after separation from CPB. caffeine group : will receive an IV infusion of caffeine citrate at 20 mg/kg (maximum 200 mg) over 10 minutes after separation from CPB. 25
Control Group The control placebo group will receive an IV infusion of volume-matched normal saline over 10 minutes after separation from CPB. The control placebo group : will receive an IV infusion of volume-matched normal saline over 10 minutes after separation from CPB. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged between 1-7 year American Society of Anesthesiologists physical status II undergoing scheduled elective simple congenital heart disease correction history of clinically significant pulmonary hypertension hepatic, renal neurological dysfunction(history of stroke, documented increased intracranial tension, history of intra cranial hemorrhage) mental retardation known allergy to drugs emergency surgeries redo surgeries Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 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 16/07/2023 Mansoura Faculty of MedicineInstitutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 elgomhouria street mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Extubation time (minutes) 6 hours postoperative.
Secondary Outcome Emergence delirium (ED will be assessed with the Pediatric Anesthesia Emergence Delirium (PAED) scale, which consists of 5 psychometric items describing emergence behavior, scores ranging from 0 to 20). will be assessed upon extubation and every 5 minutes thereafter until 30 minutes after extubation
Secondary Outcome Postoperative FLACC pain score . upon extubation and every 5 minutes thereafter until 30 minutes after extubation
Secondary Outcome Hemodynamic parameters such as heart rate (HR), Mean arterial blood pressure (MAP) intraoperative and 6 h postoperative.
Secondary Outcome The total dose of fentanyl consumption first postoperative 24 hours.
Secondary Outcome Time to first rescue analgesia 24h postoperative.
Secondary Outcome Intensive care unit (ICU) length of stay 24h postoperative.
Secondary Outcome Preoperative and post operative MMSE score. the day before surgery, and the postoperative testing session will be performed 3 days after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed refaat abourezk 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Refaat abouRezk 2 El-Gomhouria Street Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Refaat abouRezk ahmedrefaat@mans.edu.eg +201096958793 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura Egypt assistant lecturer of anesthesia facultyof medicine mansoura university
Role Name Email Phone Street address
Public Enquiries ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-GomhouriaStreet
City Postal code Country Position/Affiliation
mansoura Egypt Assistant professor of anesthesiafacultyof medicine Mansoura universityEgypt
Role Name Email Phone Street address
Scientific Enquiries ahmed refaat abourezk ahmedrefaat@mans.edu.eg +201096958793 2 El-GomhouriaStreet
City Postal code Country Position/Affiliation
mansoura Egypt assistant lecturer of anesthesia facultyof medicine mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices) will be reported.We will individual participate data and share it through thePubMed indexed journal. IPD that will be generated from this study will be shared upon request from the researchers and permission from the University research and publication director. Informed Consent Form Study Protocol Beginning 6months and ending 12months following article publication. We will individual participate data and share it through the PubMed indexed journal.
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