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.: PACTR202408666586819 Date of Approval: 15/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preemptive ketamine versus dexmedetomidine in decreasing oculo-cardiac reflex in pediatric strabismus surgery.
Official scientific title Effect of Pre-emptive Intravenous Ketamine versus Dexmedetomidine on Oculocardiac Reflex (OCR) Among Schoolchildren during Strabismus Surgery: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Many factors can affect the incidence of oculo-cardiac reflex (OCR) during strabismus surgery including preoperative anxiety, topical anesthesia, young age, medication affecting vagal tone and the anesthetic agents. Because of limited usage of regional anesthesia in pediatrics, systemic drugs are sought to modulate this reflex. Ketamine has intrinsic analgesic and amnestic properties, causes the sympatho-neuronal release of norepinephrine, and inhibits the efferent cardiac vagal drive by its central vagolytic action. Dexmedetomidine produces analgesia and sedation, reduces delirium and agitation, and provides stabilizing effects on cardiovascular function with debatable effect on OCR. This study is designed to compare the preventive effect of intravenous ketamine and intravenous DEX on the OCR among schoolchildren patients undergoing strabismus surgery. The incidence of any intraoperative decrease in HR of equal to or more than 20% on pulse oximetry and ECG or presence of arrhythmias in the form of ventricular ectopy, ventricular fibrillation or AV block on ECG is the primary outcome. Postoperative Wong–Baker Faces Pain Rating Scale score, incidence and severity of postoperative vomiting, and incidence of postoperative desaturation are the secondary outcomes.
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 Prevention
Anticipated trial start date 01/06/2024
Actual trial start date 01/08/2024
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/01/2025
Anticipated target sample size (number of participants) 87
Actual target sample size (number of participants) 96
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intravenous infusion of normal saline 10 ml once 15 minutes before induction of general anesthesia over 10 minutes 15 minutes before induction of anesthesia, a peripheral intravenous cannula will be inserted in the presence of one of their parents and the study drug (saline) will be injected over 10 minutes. 32 Placebo
Experimental Group Intravenous infusion of ketamine 0.15 mg/kg in 10 ml normal saline once 15 minutes before induction of general anesthesia. Over 10 minutes A peripheral intravenous cannula will be inserted in the presence of one of their parents and the study drug (ketamine) will be injected over 10 minutes. 32
Experimental Group Intravenous infusion of dexmedetomidine 0.5 μg/kg in 10 ml normal saline once 15 minutes before induction of general anesthesia. Over 10 minutes A peripheral intravenous cannula will be inserted in the presence of one of their parents and the study drug (dexmedetomidine) will be injected over 10 minutes 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schoolchildren patients aged 6-18 years old Both sexes Scheduled for strabismus surgery Classified as class I or II according to the American Society of Anesthesiologists (ASA) physical status score Legal guardians’ refusal Allergy to study drugs or contraindications for the use of them ASA physical status class lll or higher Patients with Severe cardiovascular disease; preoperative bradycardia or preoperative atrioventricular block on clinical examination. Patients with mental illness (history/medical record) or with a developmental delay or neurological disease. Children having a cardiac pacemaker, or taking any heart rate modifying drugs. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 18 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 21/07/2024 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Al-gumhuria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Any intraoperative decrease in HR of equal to or more than 20% on pulse oximetry and ECG or presence of arrhythmias in the form of ventricular ectopy, ventricular fibrillation or AV block on ECG. Once occurred at any time point intraoperatively
Secondary Outcome Postoperative Wong–Baker Faces Pain Rating Scale score Throughout postoperative 24 hours
Secondary Outcome The incidence and number of episodes of vomiting Throughout postoperative 24 hours
Secondary Outcome The incidence of postoperative desaturation Throughout the postoperative 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ophthalmic center in Mansoura University Hospitals Al-gumhuria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Al-gumhuria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Al-gumhuria street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator May Elsherbiny mayelsherbiny@yahoo.com 01007193959 Algomhuria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mohammed Nashaat Moh_nashaat@mans.edu.eg 01092323198 Al-gomhuria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohasseb a_medhat88@mans.edu.eg 01001272216 Abu-Hurirah st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. In addition, Study protocol, Statistical Analysis Plan, and Analytic Code will be shared after 3 months till 5 years following article publication by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website. Analytic Code,Statistical Analysis Plan,Study Protocol After 3 months till 5 years following article publication To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.
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