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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

NCT07191652 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Ear Throat Nose Surgery
  • Delirium - Postoperative
  • Pain Postoperative

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Ayşe Ç Tütüncü, Professor · Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  • Pınat Kendigelen, associate professor · Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  • İlayda Bilgili Altuntaş, Physician · Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2026-05-11
Completion
2026-05-11

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191652 on ClinicalTrials.gov