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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202412599188741 Date of Registration: 23/12/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The role of a low dose of Propofol before awake extubation among children with upper respiratory tract infection: a prospective randomized controlled trial.
Official scientific title The role of a low dose of 0.5 mg/kg of Propofol before awake extubation among children with upper respiratory tract infection: a prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Children with URTI have an increased risk of perioperative respiratory adverse events (PRAEs), mainly bronchospasm and laryngospasm. The extubation is the most critical moment. In the literature, some studies reported the benefits of a low-dose bolus of 0.5 mg/kg of propofol at extubation in reducing the incidence of laryngospam. However, this approach of extubation after pediatric anesthesia was not used in children with URTI. The aim of our study is to assess the impact of a low dose of 0.5 mg/kg before awake extubation among children with URTI on the incidence of perioepartive respiratory adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2024
Actual trial start date
Anticipated date of last follow up 15/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Active, not 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo group received normal saline just before extubation one bolus When the child is fully awake, received normal saline 150 Placebo
Experimental Group Propofol group when the child is fully awake after pediatric anesthesia, he/she received 0.5 mg/kg of propofol just before extubation one bolus when the child is fully awake after pediatric anesthesia, he/she received 0.5 mg/kg of propofol just before extubation 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children aged under 2 months –6 years suffering from mild to modrate common cold (URTI) undergoing surgical intervention requiring general anesthesia and mechanical ventilation anesthesia duration > 30 min COLDS score < 15 non-operating room anesthesia severe URTI (fever>38;5) , wheezing, green runny nose, COLDS score >15 Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 2 Month(s) 6 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 05/11/2024 Ethics committe of the faculty of medicine of sfax
Ethics Committee Address
Street address City Postal code Country
avenue majida boulila sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of respiratory adverse events defined by the incidence of bronchospasm, laryngospasm, airway obstruction, aspiration, or any other cause of oxygen desaturation during the day following surgery
Secondary Outcome intensive care referral the day following surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
hedi chaker university hospital el ain road km 0.5 sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hedi Chaker University Hospital el ain road Km 0.5 SFAX 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hedi chaker university hospital el ain road km 0.5 sfax 3000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator anouar jarraya jarraya_anouar@medecinesfax.org +21692553300 el ain road km 0.5
City Postal code Country Position/Affiliation
sfax 3000 Tunisia head of pediatric anesthesia department
Role Name Email Phone Street address
Scientific Enquiries manel kammoun manelkammoun6@gmail.com +21658157976 el ain road km 0.5
City Postal code Country Position/Affiliation
SFAX 3000 Tunisia pediatric anesthesiologist
Role Name Email Phone Street address
Public Enquiries kamel kolsi kammoul.kolsi@gmail.com +21658158254 el ain road km 0.5
City Postal code Country Position/Affiliation
sfax 3000 Tunisia anesthesiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial after deidentification can be shared Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication No end date Anyone who wishes to access the data for any purpose
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 10/12/2024 add missing information Children with URTI have an increased risk of perioperative respiratory adverse events (PRAEs), mainly bronchospasm and laryngospasm. The extubation is the most critical moment. In the literature, some studies reported the benefits of a low-dose bolus of 0.5 mg/kg of propofol at extubation in reducing the incidence of laryngospam. However, this approach of extubation after pediatric anesthesia was not used in children with URTI. Children with URTI have an increased risk of perioperative respiratory adverse events (PRAEs), mainly bronchospasm and laryngospasm. The extubation is the most critical moment. In the literature, some studies reported the benefits of a low-dose bolus of 0.5 mg/kg of propofol at extubation in reducing the incidence of laryngospam. However, this approach of extubation after pediatric anesthesia was not used in children with URTI. The aim of our study is to assess the impact of a low dose of 0.5 mg/kg before awake extubation among children with URTI on the incidence of perioepartive respiratory adverse events.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/12/2024 corrections all data can be shared after April 2025 All the individual participant data collected during the trial after deidentification can be shared
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/12/2024 corrections 2 months Immediately following publication No end date
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/12/2024 corrections controlled access under request Anyone who wishes to access the data for any purpose
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/12/2024 corrections Study Protocol, Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code