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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-20

Study Completion Date

2025-12-25

Brief Summary

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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.

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Detailed Description

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It has been suggested that ear, nose, and throat (ENT) surgeries may be a risk factor for the development of delirium.

This study will be conducted retrospectively following approval from the Ethics Committee, by reviewing the medical records of pediatric patients who underwent ENT surgery at Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Otorhinolaryngology between January 2024 and June 2025. In our clinic, both opioid-restricted and non-restricted general anesthesia techniques are routinely applied in pediatric ENT surgeries, and the data of these patients will be analyzed retrospectively.

Opioid-based and opioid-free anesthesia techniques are routinely employed in pediatric ENT procedures in our institution. This study aims to retrospectively evaluate the incidence of emergence agitation and delirium associated with these different anesthesia approaches.

For patients in both groups, the following data will be extracted from medical records: age, sex, weight, diagnosis, comorbidities, presence of allergies, type and duration of surgery, anesthesia technique (opioid-based or opioid-free), frequency and duration of hypotension based on age-specific mean arterial pressure percentiles, total amount of opioids used or total lidocaine dose, BIS suppression time, average BIS value, requirement for additional analgesics during recovery, time from discontinuation of inhalational agents to extubation, and length of stay in the recovery room.

In the postoperative period, all patients are routinely assessed in the recovery unit using PAED, PONV, and either FLACC or NRS scores, which will be retrieved from patient records. Late postoperative pain and patient satisfaction will be assessed based on data obtained from routine surgical outpatient follow-ups.

Patients aged 2 to 18 years with an ASA physical status of I-II will be included in the study. Patients with liver failure, renal failure, advanced heart block (second or third degree), history of cerebrovascular events, regular opioid use, will be excluded.

The primary objective of this study is to retrospectively evaluate the incidence of emergence agitation and delirium following routinely applied opioid-based and opioid-free anesthesia techniques in pediatric patients undergoing ENT surgery. The secondary objective is to retrospectively assess late postoperative pain and patient satisfaction.

Conditions

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Ear Throat Nose Surgery Delirium - Postoperative Pain Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Opioid Anesthesia

In Group A, according to retrospective patient records, patients who underwent general anesthesia induction with sevoflurane or intravenous propofol, fentanyl, and rocuronium, and whose anesthesia was maintained with sevoflurane and a remifentanil infusion titrated according to BIS monitoring, were included. Perioperative data-including anesthesia induction details, administered drugs and their dosages, and hemodynamic parameters-will be obtained from anesthesia monitoring records.

Pain and agitation scores will be assessed using the FLACC or NRS and PAED scales, which are routinely applied in the pediatric recovery unit, and these data will be extracted from patient records. Late postoperative pain and patient satisfaction will be evaluated based on follow-up data recorded during routine postoperative outpatient clinic visits.

No interventions assigned to this group

Opioid-free Anesthesia

In Group B, according to retrospective patient records, patients who underwent general anesthesia induction with intravenous propofol or sevoflurane, magnesium sulfate, lidocaine, and rocuronium, and whose anesthesia was maintained with magnesium sulfate, lidocaine, dexmedetomidine, and sevoflurane-titrated according to BIS monitoring-were included. Perioperative data, including anesthesia induction details, administered drugs and their dosages, as well as hemodynamic parameters, will be obtained from anesthesia monitoring records.

Pain and agitation scores will be assessed using the FLACC or NRS and PAED scales, which are routinely applied in the pediatric recovery unit, and these data will be retrieved from patient records.Late postoperative pain and patient satisfaction will be evaluated based on follow-up data recorded during routine postoperative outpatient clinic visits.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No