Ear Throat Nose SurgeryNCT07191652
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
An observational study of Ear Throat Nose Surgery and Delirium - Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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]. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Ear Throat Nose Surgery, Delirium - Postoperative, Pain Postoperative
- Type of treatment
- Injection or infusion
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2026to 11 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Aged 2-18 years
- ASA I-II
- Undergoing elective tonsillectomy, adeoidectomy, cochlear implant surgery under general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Faculty of Medicine
Istanbul, Istanbul
About this study
Official title: 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.
Read the 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.
- Keywords
- Opioid-Free Anesthesia, Postoperative Agitation-Delirium, Quality of Postoperative Recovery, Monitored with Perioperative Bispectral Index, ear throat and nose surgery
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15th minutes
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1st hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start25 Mar 2026
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ear Throat Nose SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlayda Bilgili Altuntaş, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Ç Tütüncü, Professor, Study director, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of MedicinePınat Kendigelen, associate professor, Study chair, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicineİlayda Bilgili Altuntaş, Physician, Principal investigator, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191652
- Sponsor's protocol ID
- E-74555795-050.04-1369719
- Status last verified
- May 2026
- First submitted
- 26 Sep 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17179249Yang 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.
PubMed 36203819
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07191652
- Acronym / sponsor ID
- E-74555795-050.04-1369719
- Keywords
- Opioid-Free Anesthesia, Postoperative Agitation-Delirium, Quality of Postoperative Recovery, Monitored with Perioperative Bispectral Index, ear throat and nose surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Aged 2-18 years
- ASA I-II
- Undergoing elective tonsillectomy, adeoidectomy, cochlear implant surgery under general anesthesia.
Key exclusion criteria (7 listed)
- Patients with ASA 3,4, 5, or 6
- Liver failure
- Advanced heart block (second and third degree)
- Acute cerebrovascular events
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
WATCHA Score
Time frame: 1 hour
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.
Pediatric Agitation and Delirium Scale
Time frame: 1 hour
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.
WATCHA score
Time frame: 15th minutes
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.
Pediatric Agitation and Delirium Scale
Time frame: 15th minutes
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.
6 secondary outcomes
FLACC
Time frame: 1 hour
FLACC
Time frame: 15th minutes
Postoperative quality of recovery
Time frame: 1 month
Quality of Recovery Score
Time frame: 1ST week
NRS
Time frame: 15th minutes
NRS
Time frame: 1st hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 17179249Vlajkovic 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.
- Background: PubMed 36203819Yang 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.
- Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled StudyLink provided by the sponsor.
- Emergence delirium in children: many questions, few answersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Ç Tütüncü, Professor study director
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
Pınat Kendigelen, associate professor study chair
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
İlayda Bilgili Altuntaş, Physician principal investigator
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ear Throat Nose Surgery and Delirium - Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WATCHA Score (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07191652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.