About this trial
The goal of this clinical trial is to assess whether preoperative anesthesia teleconsultation is at least equivalent to in-person consultation in preventing perioperative respiratory adverse events (such temporary reduction in oxygen levels in the blood) in the operating room and in the first 24 hours after the surgery in pediatric adenotonsillectomy.
Researchers will compare the teleconsultation to in-person consultation to see if there is a difference in the frequency of respiratory adverse events in the operating room and during the first 24 hours after adenotonsillectomy.
Participants will:
\- undergo a traditional in-person anesthesiology consultation scheduled at the hospital or a online preoperative anesthesiology teleconsultation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients (up to 16 years of age) undergoing elective tonsillectomy or adenotonsillectomy
ASA (American Society of Anesthesiologists) physical status I to III,
Patients who have a parent or legal guardian able and willing to provide informed consent.
Disqualifiers
Parent or guardian unable or unwilling to provide informed consent,
Refusal to participate by parent/guardian,
Patients with contraindications to general anesthesia,
Known allergy to any drugs used in the anesthetic protocol.
Trial design
Parallel
Treatments tested in this trial
Face-to-Face Preanesthesia Consultation
Other interventionParticipants receive a standard preoperative anesthesia consultation in person at the hospital
Telemedicine Preanestehsia Consultation
Other interventionParticipants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of perioperative respiratory adverse events (PRAE)
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing, recorded intraoperatively and up to 24 hours postoperatively.
Incidence of PRAE (perioperative respiratory adverse events)
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing
Secondary outcomes
Consultation duration
Time in minutes from the start to the end of the preoperative anesthesia consultation (either in-person or via telemedicine). The duration will be recorded by the anesthesiologist at the end of each consultation
preoperative assessment adequacy
Day-of-surgery cancellation rate
Preoperative anxiety in parents
Parental anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), a validated questionnaire with six self-reported items rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Higher scores indicate greater anxiety and information need.
Preoperative anxiety in paediatric patients aged 8 years and older
For children aged 8 years and older, the Visual Analogue Scale for Anxiety (VAS-A) will be used, a self-reported 10-cm visual analogue with facial expressions ranging from "very distressed" to "very happy." Scores are recorded from 0 to 10, with higher scores indicating greater anxiety
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrea Saporito
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Sponsor institution