Clinical Trial

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

Completed
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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.
Protocol Amendment History 3 changes
critical Trial completed 2026-05-13
notable Primary completion pushed: 2026-04 -> 2026-05-11 2026-05-13
minor Completion pushed: 2026-04 -> 2026-05-11 2026-05-13
Trial Details
NCT Number NCT07191652
Lead Sponsor Istanbul University - Cerrahpasa
Conditions Ear Throat Nose Surgery, Delirium - Postoperative, Pain Postoperative
Enrollment 128 participants
Start Date 2026-03-25
Primary Completion 2026-05-11 (estimated)
Study Completion 2026-05-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-12