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

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.

Study Overview

• Status: Completed
• Conditions: Pain Postoperative; Delirium - Postoperative; Ear Throat Nose Surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye)
      • Cerrahpasa Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:The study will include 126 patients

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC	The secondary aim is to assess postoperative pain scores with NRS or FLACC score(0 to 10 point, with zero meaning "no pain" and 10 meaning "the worst pain imaginable") at 1 hour	1 hour
FLACC	The secondary aim is to assess postoperative pain scores with NRS or FLACC score(0 to 10 point, with zero meanin "no pain" and 10 meaning "the worst pain imaginable") at 1 mounth	15th minutes
Postoperative quality of recovery	The secondary aim is to assess postoperative quality of recovery score (QoR-15- 0 to 150 point, with zero meaning "the worst recovery point" and 150 meaning "the best recovery point") at 1 mounth	1 month
Quality of Recovery Score	The secondary aim is to assess postoperative quality of recovery score (QoR-15- 0 to 150 point, with zero meaning "the worst recovery point" and 150 meaning "the best recovery point") at 1st week	1ST week
NRS	The secondary aim is to assess postoperative pain scores with NRS or FLACC score(0 to 10 point, with zero meaning "no pain" and 10 meaning "the worst pain imaginable") at 1 hour	15th minutes
NRS	The secondary aim is to assess postoperative pain scores with NRS or FLACC score(0 to 10 point, with zero meaning "no pain" and 10 meaning "the worst pain imaginable") at 1 hour	1st hour

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Principal Investigator: İlayda Bilgili Altuntaş, Physician, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine; Study Director: Ayşe Ç Tütüncü, Professor, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine; Study Chair: Pınat Kendigelen, associate professor, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Actual): May 11, 2026
• Study Completion (Actual): May 11, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Actual): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Opioid-Free Anesthesia; Postoperative Agitation-Delirium; Quality of Postoperative Recovery; Monitored with Perioperative Bispectral Index; ear throat and nose surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Pain, Postoperative
• Other Study ID Numbers: E-74555795-050.04-1369719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No