Comparing Dexmedetomidine, Ketamine, and Magnesium for Reducing Agitation After Anesthesia in Children
Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics : A Prospective, Double-blinded, Randomized Controlled Study.
This study is testing whether dexmedetomidine, ketamine, or magnesium can help reduce agitation in young children after they wake up from anesthesia during heart procedures.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06077539 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of dexmedetomidine, ketamine, and magnesium sulfate in preventing emergence agitation in children aged 2-5 years following sevoflurane anesthesia during cardiac catheterization. The study aims to determine which of these interventions is most effective in reducing post-operative agitation, a common issue that can lead to increased nursing care and costs. Participants will be monitored for agitation levels using the Pediatric Anesthesia Emergence Delirium Scale (PAED) after their procedures. The trial is unique as it is the first to compare these three medications in this specific context.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-5 years, weighing more than 6 kg, scheduled for cardiac catheterization procedures lasting no longer than 3 hours.
Not a fit: Patients with psychological disorders, cognitive delays, or those on sedative or anticonvulsant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of emergence agitation in pediatric patients, enhancing recovery and reducing healthcare costs.
How similar studies have performed: While there have been studies on individual medications for emergence agitation, this is the first to compare dexmedetomidine, ketamine, and magnesium sulfate together, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status II * ages from 2-5 years. * weight more than 6 kg. * scheduled for cardiac catheterization procedure not exceeding 3 hours. Exclusion Criteria: * psychological disorder or cognitive delay. * chronic or acute intake of any sedative drug or anticonvulsant drugs. * Any neurological condition that will limit ability to communicate with, or understand a practitioner. * those with coexisting renal diseases , any reported allergy to the given medications. * legal guardian refusal .
Where this trial is running
Giza
- Amany Hassan Saleh — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Amany Saleh, MD — Cairo University
- Study coordinator: Amany H Saleh, MD
- Email: dr_amanyhassan@hotmail.com
- Phone: 01224259808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.