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 | Completed DMC

• 1 other identifier: E-74555795-050.04-1369719
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Opioid-Free Anesthesia; Postoperative Agitation-Delirium; Quality of Postoperative Recovery; Monitored with Perioperative Bispectral Index; ear throat and nose surgery

Outcome Measures

Primary Outcomes (4)

• WATCHA Score

  The primary aim of the study is to measured the effects of opioid-based versus opioid-free anesthesia procedures on agitation and delirium with WATCHA score(The WATCHA scale has 5 levels: 0-asleep, 1-calm, 2-crying but can be controlled, 3-crying that cannot be controlled and 4-agitated and trashing around) in the postoperative recovery period in children undergoing Ear, Nose, and Throat (ENT) surgeries.

  1 hour

• Pediatric Agitation and Delirium Scale

  The primary aim is to assess postoperative agitation scores with Pediatric Agitation and Delirium Scale( all items are scored on a 0-4 point scale as occuring not at all, just a little, quite a bit, very much, or extremely) in the postoperative recovery period in children undergoing Ear, Nose, and Throat (ENT) surgeries.

  1 hour

• WATCHA score

  The primary aim of the study is to measured the effects of opioid-based versus opioid-free anesthesia procedures on agitation and delirium with WATCHA score(The WATCHA scale has 5 levels: 0-asleep, 1-calm, 2-crying but can be controlled, 3-crying that cannot be controlled and 4-agitated and trashing around) in the postoperative recovery period in children undergoing Ear, Nose, and Throat (ENT) surgeries.

  15th minutes

• Pediatric Agitation and Delirium Scale

  The primary aim is to assess postoperative agitation scores with Pediatric Agitation and Delirium Scale( all items are scored on a 0-4 point scale as occuring not at all, just a little, quite a bit, very much, or extremely) in the postoperative recovery period in children undergoing Ear, Nose, and Throat (ENT) surgeries.

  15th minutes

Secondary Outcomes (6)

• FLACC

  1 hour

• FLACC

  15th minutes

• Postoperative quality of recovery

  1 month

• Quality of Recovery Score

  1ST week

• NRS

  15th minutes

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population will consist of 126 pediatric patients aged between 2 and 18 years, who are classified as ASA physical status I or II and are scheduled to undergo elective ear, nose, and throat (ENT) surgery under general anesthesia. These patients will be included based on the eligibility criteria and will be evaluated retrospectively. Patients will be excluded from the study if they fall under ASA classifications III, IV, V, or VI, or if they have a diagnosis of liver failure, advanced heart block (second or third degree), acute cerebrovascular events, mental retardation, or have a tracheostomy. Additionally, any patient or guardian who declines participation will also be excluded.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Cerrahpasa Faculty of Medicine

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.

  PMID: 17179249 BACKGROUND

• Yang X, Lin C, Chen S, Huang Y, Cheng Q, Yao Y. Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study. Drug Des Devel Ther. 2022 Sep 30;16:3413-3420. doi: 10.2147/DDDT.S381611. eCollection 2022.

  PMID: 36203819 BACKGROUND

Related Links

• Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study
• Emergence delirium in children: many questions, few answers

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Ayşe Ç Tütüncü, Professor

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  STUDY DIRECTOR

• Pınat Kendigelen, associate professor

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  STUDY CHAIR

• İlayda Bilgili Altuntaş, Physician

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 25, 2025
• Study Start: March 25, 2026
• Primary Completion: May 11, 2026
• Study Completion: May 11, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)