Measuring blood loss in children undergoing tonsil surgery with different muscle relaxants
The Effects of Nondepolarizing Muscle Relaxants During General Anesthesia on Perioperative and Postoperative Bleeding in Pediatric and Adult Patients Undergoing Tonsillectomy
PHASE4 · University Hospital of Split · NCT06399445
This study is testing whether using a specific muscle relaxant during tonsil surgery helps reduce blood loss in young children aged 3 to 7.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | University Hospital of Split (other) |
| Locations | 1 site (Split) |
| Trial ID | NCT06399445 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare intraoperative and postoperative blood loss in children undergoing adenotonsillectomy while using nondepolarizing muscle relaxants. A total of 60 children aged 3 to 7 years will be randomly assigned to receive either rocuronium bromide or no muscle relaxant during general anesthesia. The study will monitor vital signs and blood loss throughout the procedure to determine the impact of the muscle relaxant on surgical outcomes. The trial is approved by the local ethical committee and will follow strict inclusion and exclusion criteria to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 7 years classified as ASA I or II, scheduled for adenotonsillectomy due to recurrent tonsillar infections or obstructive sleep apnea.
Not a fit: Patients with contraindications for general anesthesia, coagulation disorders, or anemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced blood loss during adenotonsillectomy in children.
How similar studies have performed: While there is limited literature specifically addressing blood loss in adenotonsillectomy with muscle relaxants, similar studies in other surgical contexts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * conventional cold tonsillectomy and curettage adenoidectomy * American Society of Anesthesiologists (ASA) physical status classification system: I, II aged between 3 and 7 years Exclusion Criteria: * Contraindications for general anesthesia, coagulation disorders, anemia,identification of an infection during systemic examinations
Where this trial is running
Split
- University Hospital Split — Split, Croatia (RECRUITING)
Study contacts
- Principal investigator: Ines Petrović — University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
- Study coordinator: Ines Petrović
- Email: inepetrovi@gmail.com
- Phone: 0919827708
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.
Conditions: Anesthesia, Neuromuscular Blockade, Intraoperative Bleeding, Intraoperative Blood Loss, Post Operative Hemorrhage, Anesthesia Complication, Adenotonsillectomy, Tonsillectomy