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NCT07902193
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Conditions: Neuromuscular Blockade, Delayed Emergence From Anesthesia, Emergence Agitation
Sex: All
Ages: 2 Years – 17 Years
Healthy volunteers: No
Enrollment: 140
Sponsor: Namik Kemal University
Location: Tekirdağ Namık Kemal University Hospital, Department of Anesthesiology and Reanimation Tekirdağ
Summary
Sugammadex is routinely used to reverse rocuronium-induced neuromuscular blockade in children. In clinical practice, it is given either while the child is still deeply anesthetized or after the anesthetic has lightened. Whether this timing affects the recovery profile is unknown.
This prospective observational study will compare time to extubation, emergence agitation and perioperative complications in children aged 2 to 17 years who receive sugammadex under deep (1.0 to 1.1 minimum alveolar concentration \[MAC\]) versus light (0.3 to 0.4 MAC) sevoflurane anesthesia, according to the routine practice of the attending anesthesiologist. The investigators will not influence any clinical decision.
Eligibility Criteria
Inclusion Criteria:
* Age 2 to 17 years
* American Society of Anesthesiologists (ASA) physical status I
* Elective adenoidectomy or adenotonsillectomy under general anesthesia maintained with sevoflurane
* Neuromuscular blockade with rocuronium 0.6 milligrams per kilogram (mg/kg)
* Sugammadex 4 mg/kg administered at least 60 minutes after rocuronium
* Planned extubation in the operating room
* Written informed consent from a parent or legal guardian
Exclusion Criteria:
* ASA physical status II or higher
* Neuromuscular disease (e.g., myasthenia gravis, muscular dystrophy)
* History of hepatic or renal dysfunction
* Regular use of drugs affecting neuromuscular transmission (e.g., steroids, aminoglycosides, magnesium)
* History of prematurity (less than 37 weeks of gestation)
* Morbid obesity (body mass index \[BMI\] above the 95th percentile for age and sex)
* Serious cardiac, pulmonary or neurological disease
* Known allergy or hypersensitivity, particularly to sugammadex or rocuronium
* End-tidal sevoflurane minimum alveolar concentration (MAC) at the time of sugammadex administration outside the defined cohort ranges
* Unplanned intraoperative events (e.g., major bleeding, prolonged surgery, need for additional drugs)
* Refusal of consent by a parent or legal guardian
Source: ClinicalTrials.gov (NCT07902193). StuddyBuddy aggregates publicly available trial information.