Respiratory Complication
Conditions
Brief summary
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy
Interventions
sugammadex as reversal agent
DRUGNeostigmine
neostigmine as a reversal agent
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
Exclusion criteria
* a recent history of upper respiratory tract infection within 2 weeks of surgery * allergic reaction to sugammadex * renal failure * liver failure * arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative respiratory adverse events | from induction of anesthesia to end of operation, about 3 hours | the incidence of overall perioperative respiratory adverse events; oxygen desaturation \< 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac arrest | from induction of anesthesia to end of operation, about 3 hours | documented chest compressions/defibrillation/cardioversion |
| Anaphylaxis | from induction of anesthesia to end of operation, about 3 hours | administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction |
| bradycardia | from induction of anesthesia to end of operation, about 3 hours | administration of IV atropine, glycopyrrolate, epinephrine, ephedrine |
| Bronchospasm | from induction of anesthesia to end of operation, about 3 hours | administration of albuterol, epinephrine |
| Nausea and vomiting | from induction of anesthesia to end of operation, about 3 hours | — |
| Allergic reaction | from induction of anesthesia to end of operation, about 3 hours | redness, urticaria, wheeze |
Countries
South Korea
Outcome results
None listed