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.: PACTR202109686219888 Date of Approval: 14/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of intraoperative magnesium sulphate versus ketamine on emergence agitation in pediatric patients under sevoflurane anesthesia
Official scientific title Efficacy of intraoperative magnesium sulphate versus ketamine on emergence agitation in pediatric patients under sevoflurane anesthesia : a randomized clinical trial
Brief summary describing the background and objectives of the trial Sevoflurane is widely used as the main inhalational anesthetic agent for induction and maintenance of general anesthesia in pediatric patients. However, Emergence agitation is a frequent postoperative complication in pediatric patients receiving sevoflurane anesthesia. Various drugs were used to control postoperative emergence agitation including opioid and non- opioid medications. The aim of this study is to compare the efficacy of intraoperative ketamine and magnesium suphate infusion on the incidence and severity of emergence agitation following sevoflurane anesthesia in pediatric population, immediately after recovery in the operation room and 30 minutes after recovery in post-anesthesia care unit (PACU).
Type of trial RCT
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 18/09/2019
Actual trial start date 18/09/2019
Anticipated date of last follow up 18/09/2020
Actual Last follow-up date 18/09/2020
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Completed
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ketamine group The loading dose given before the start of surgical procedure at a dose of 1mg/kg diluted in 0.9% NaCl, then a dose of 1mg/kg/h IV infusion for the entire duration of surgery Intraoperative and 30 minutes postoperative Loading dose will be given at a dose of 1mg/kg diluted in 20 ml 0.9% NaCl given over 10 minutes followed by a dose of 1mg/kg/h IV infusion for the entire duration of surgery 26
Experimental Group Magnesium group The loading dose given before the start of the surgical procedure at a dose of 15 mg/kg diluted in 0.9% NaCl, then a dose of 10mg/kg/h IV infusion for the entire duration of surgery Intraoperative and 30 minutes postoperative The loading dose will be given before the start of surgical procedure at a dose of 30mg/kg diluted in 20 ml 0.9% NaCl over 10 minutes. Then a dose of 10mg/kg/h IV infusion for the entire duration of surgery. Concentration of solution will not exceed 1gm/25 mLS (40 mg/mL). 26
Control Group NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients aged from 4-7 years. ASA physical status 1-2. Both sex. Patients undergoing operations under general anesthesia using sevoflurane anesthesia. Type of operation: Abdominal and pelvic operations not more than 2-hour duration. Behavioral changes. Cerebral palsy and other neurological disorders. Physical or developmental delay. Sedative or anticonvulsant medication. Pre-existing renal or cardiovascular disease. Legal guardian refusal. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 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 18/09/2019 Research Ethics Committee. Faculty of Medicine. Ain Shams University.
Ethics Committee Address
Street address City Postal code Country
Abbasia. Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of emergence agitation using Pediatric Anesthesia Emergence Delirium scale immediately after recovery and 30 minutes postoperative in PACU. Immediately after recovery and 30 minutes postoperative in PACU
Secondary Outcome Time from end of surgery to removal of the ETT Time for resumption of mental orientation which can be defined as the period from discontinuation of anesthesia till the time the patient can correctly answer one of the following questions (Where are you? Or Who am I?) Time to discharge from PACU From end of surgery till 30 minutes postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine. Ain Shams University Abbasia. Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nada Mohammed Saeed Hussein Abdelhakim 15 Moustafa El- Maghraby street. Heliopolis Cairo - Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine. Ain Shams University Abbasia Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Alaa Eid Mohamed Abbasia Cairo 11591 Egypt
Prof. Dr. Dalia Abdelhamid Mohamed Nasser Abbasia Cairo 11591 Egypt
Dr. Farouk Kamal Eldeen Abd El Aziz Abbasia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nada Abdelhakim nadasaeed@med.asu.edu.eg +201001077473 15 Moustafa El Maghraby. Heliopolis
City Postal code Country Position/Affiliation
Cairo - Egypt Assistant Lecturer of Anesthesiology and Intensive Care Unit
Role Name Email Phone Street address
Scientific Enquiries Farouk Abd El Aziz dr.faroukkamal@med.asu.edu.eg +201066241179 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Anesthesiology and Intensive Care Unit
Role Name Email Phone Street address
Public Enquiries Alaa Eid dralaa_hassan@med.asu.edu.eg +201222167416 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesiology and Intensive Care Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from the study will be available for sharing upon request after publication of the study within 1 year for a period of time that will be determined by collaborators after that. The data will be deidentified and provided after review of sound proposals by collaborators. Study Protocol within a year of publication of the study Researchers who provide a methodologically sound proposal, ethical committee approval and trial registry number can contact the corresponding author within a year of publication and individual participant data that underlie the results reported in this article will be shared after deidentification (text, tables, figures, and appendices) . Requests will be reviewed by collaborators. Data can be used for individual participant meta-analysis and to gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information