RecruitingNCT07191652

The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index

The Association Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and the Quality of Postoperative Recovery in Pediatric Otolaryngology Cases Monitored With Perioperative Bispectral Index


Sponsor

Istanbul University - Cerrahpasa

Enrollment

120 participants

Start Date

Mar 25, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Delirium is a postoperative complication that hinders a child's recovery and presents challenges in assessment and management. Ear nose throat (ENT) procedures have been suggested as a risk factor for delirium\[1\]. While numerous studies have explored the effect of sevoflurane on increasing delirium\[2\], data regarding opioids remain unclear. This study aims to retrospectively evaluate the incidence of emergence agitation and delirium in pediatric patients following otolaryngology surgery under opioid and opioid-free anesthesia approaches that are routinely used in anesthetic practice for these procedures. Investigators hypothesis posits that a reduced incidence of burst suppression and opioid-free anesthesia may prevent delirium. The primary aim of this study is to retrospectively evaluate the incidence of emergence agitation and delirium following routine opioid-based and opioid-free anesthesia approaches in pediatric patients undergoing ENT surgeries. The secondary aim is to retrospectively assess late postoperative pain and patient satisfaction.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Inclusion Criteria3

  • Aged 2-18 years
  • ASA I-II
  • Undergoing elective tonsillectomy, adeoidectomy, cochlear implant surgery under general anesthesia.

Exclusion Criteria7

  • Patients with ASA 3,4, 5, or 6
  • Liver failure
  • Advanced heart block (second and third degree)
  • Acute cerebrovascular events
  • Mental retardation
  • Patients with tracheostomy
  • Those unwilling to participate

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Locations(1)

Cerrahpasa Faculty of Medicine

Istanbul, Istanbul, Turkey (Türkiye)

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NCT07191652


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