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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07191652
Enrollment
128
Registered
2025-09-25
Start date
2026-03-25
Completion date
2026-05-11
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium - Postoperative, Ear Throat Nose Surgery, Pain Postoperative

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
WATCHA Score1 hourThe 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.
Pediatric Agitation and Delirium Scale1 hourThe 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.
WATCHA score15th minutesThe 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.

Secondary

MeasureTime frameDescription
Postoperative quality of recovery1 monthThe 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
FLACC1 hourThe 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
Quality of Recovery Score1ST weekThe 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
NRS15th minutesThe 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

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORAyşe Ç Tütüncü, Professor

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

STUDY_CHAIRPınat Kendigelen, associate professor

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

PRINCIPAL_INVESTIGATORİlayda Bilgili Altuntaş, Physician

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026