AdenotonsillectomyNCT06838260
Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy
A study testing 24°C Endotracheal tube and 37°C Endotracheal tube in people with Adenotonsillectomy, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Adenotonsillectomy
- What is being tested?
- 24°C Endotracheal tube and 37°C Endotracheal tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2025to 15 Mar 2026
- Phase
- Interventional
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents who agreed to participate in the study
- Children undergoing adenotonsillectomy
- ASA 1 and 2 class patients
Who cannot join
- Emergency surgery
- Children with a history of difficult airway
- Children who have had upper airway surgery
- Presence or suspicion of upper or lower respiratory tract infection
- History of cardiac and respiratory diseases
- Patients with craniofacial malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects of Endotracheal Tube Temperature on Respiratory Complications in Children Undergoing Adenotonsillectomy
Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period.
The aim of this study was to compare the effects of using endotracheal intubation tubes at different temperatures during intubation on respiratory complications in the postoperative period in children undergoing adenotonsillectomy.
Read the detailed description
Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children. Its incidence has been increasing day by day and has almost doubled since the 1970s. In recent years, with the development of surgical techniques and anesthetic approaches, significant progress has been made in the recovery and postoperative management of these patients and morbidity has decreased significantly. The most feared complications of AT in children are respiratuar complications such as laryngospasm and bronchospasm. These complications can occur during AT or in the postoperative period, requiring rapid response by the anesthesia and surgical team and extensive postoperative monitoring. They may result in increased morbidity and prolonged hospitalization. Different methods including intravenous lidocaine, topical lidocaine, propofol, iv magnesium and the like have been proposed to reduce laryngospasm; different results have been obtained in studies. Thermal softening of endotracheal tubes (ETT) with normal warm saline before intubation has been shown to be significantly effective in reducing sore throat and hoarseness during recovery and postoperatively. The aim of this study was to compare the intraoperative and postoperative respiratory effects of using endotracheal intubation tubes at different temperatures during intubation in children undergoing adenotonsillectomy.
- Conditions
- Adenotonsillectomy
- Being tested
- 24°C Endotracheal tube, 37°C Endotracheal tube
- Keywords
- Adenotonsillectomy in children, Endotracheal tube temperature, Respiratory complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24°C Endotracheal tubeOther
A disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 24°C for the T1 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study.
37°C Endotracheal tubeOther
A disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 37°C for the T2 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study.
| Study group | Role | What they receive |
|---|---|---|
| Group T24 (24°C Endotracheal tube) | Active comparator | Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation. Receives: Other: 24°C Endotracheal tube |
| Group T37 (37°C Endotracheal tube) | Active comparator | Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation. Receives: Other: 37°C Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of laryngospasm
The rates of laryngospasm occurring in the participants will be determined and compared between the 2 groups
Measured: From extubation until postoperative 2. hour
Rate of bronchospasm
The rates of bronchospasm occurring in the participants will be determined and compared between the 2 groups
Measured: From extubation until postoperative 2. hour
Rate of desaturation
The rates of desaturation occurring in the participants will be determined and compared between the 2 groups
Measured: From extubation until postoperative 2. hour
Secondary outcomes (5)
Heart rate
Heart rate (HR) (bpm) will be recorded and data will be compared between groups
Measured: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Mean arterial pressure (MAP) mmHg
Mean arterial pressure (MAP) (mmHg) will be recorded and data will be compared between groups
Measured: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Oxygen saturation
Oxygen saturation (SpO2), (%) will be recorded and data will be compared between groups
Measured: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Intraopearative anaesthesia machine respiratory data
End-tidal carbon dioxide (EtCO2) (mmHg) will be recorded and data will be compared between groups
Measured: 4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)
Intraopearative anaesthesia machine respiratory data 2
Maximum pressure measured at end inspiration (Ppeak) will be recorded and data will be compared between groups Mean airway pressure (Pmean) will be recorded and data will be compared between groups
Measured: 4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start2 Mar 2025
- Primary completion31 Jan 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. Children intubated with an endotracheal tube which 24° celcius (Group T24), Children intubated with an endotracheal tube which 37° celcius (Group T37)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mursel Ekinci, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838260
- Sponsor's protocol ID
- Bursa City Hospital 11
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share IPD
Publications
Jeyakumar A, Fettman N, Armbrecht ES, Mitchell R. A systematic review of adenotonsillectomy as a risk factor for childhood obesity. Otolaryngol Head Neck Surg. 2011 Feb;144(2):154-8. doi: 10.1177/0194599810392328.
PubMed 21634056Orestes MI, Lander L, Verghese S, Shah RK. Incidence of laryngospasm and bronchospasm in pediatric adenotonsillectomy. Laryngoscope. 2012 Feb;122(2):425-8. doi: 10.1002/lary.22423. Epub 2012 Jan 17.
PubMed 22252947Marzban S, Haddadi S, Naghipour MR, Sayah Varg Z, Naderi Nabi B. The effect of intravenous magnesium sulfate on laryngospasm after elective adenotonsillectomy surgery in children. Anesth Pain Med. 2014 Feb 28;4(1):e15960. doi: 10.5812/aapm.15960. eCollection 2014 Feb.
PubMed 24660159Mohseni M, Farahmand Rad R, Jafarian AA, Zarisfi AH, Masoudi N. The Effect of Softening of Endotracheal Tubes on the Decrement of Postoperative Hoarseness and Sore Throat. Anesth Pain Med. 2022 Nov 15;12(5):e123910. doi: 10.5812/aapm-123910. eCollection 2022 Oct.
PubMed 36937172Yu Y, Jia Q, Zhou L, Liu Z, Liang S, Yang Z, Wan Q. Appropriate tube temperature for fiberoptic bronchoscope-guided intubation of thermally softened double-lumen endotracheal tubes: A CONSORT-compliant article. Medicine (Baltimore). 2022 Oct 7;101(40):e29999. doi: 10.1097/MD.0000000000029999.
PubMed 36221346Komasawa N, Nishihara I, Tatsumi S, Minami T. Prewarming of the i-gel facilitates successful insertion and ventilation efficacy with muscle relaxation: a randomized study. J Clin Anesth. 2014 Dec;26(8):663-7. doi: 10.1016/j.jclinane.2014.08.009. Epub 2014 Nov 18.
PubMed 25468575Dikici M, Kaciroglu A, Cevikkalp E, Aras T, Eglen MY, Alan Y, Tuzemen G, Aydogmus I, Ekinci M. Effect of Thermal Softening of Endotracheal Tubes on Perioperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy: A Randomized Controlled Trial. Paediatr Anaesth. 2026 Sep 11. doi: 10.1002/pan.70312. Online ahead of print.
PubMed 42725682
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Endotracheal Tube Temperature on Respiratory Complications in Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT06838260
- Acronym / sponsor ID
- Bursa City Hospital 11
- Conditions
- Adenotonsillectomy
- Keywords
- Adenotonsillectomy in children, Endotracheal tube temperature, Respiratory complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 20 Feb 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.
Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period.
The aim of this study was to compare the effects of using endotracheal intubation tubes at different temperatures during intubation on respiratory complications in the postoperative period in children undergoing adenotonsillectomy.
Detailed description
Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children. Its incidence has been increasing day by day and has almost doubled since the 1970s. In recent years, with the development of surgical techniques and anesthetic approaches, significant progress has been made in the recovery and postoperative management of these patients and morbidity has decreased significantly. The most feared complications of AT in children are respiratuar complications such as laryngospasm and bronchospasm. These complications can occur during AT or in the postoperative period, requiring rapid response by the anesthesia and surgical team and extensive postoperative monitoring. They may result in increased morbidity and prolonged hospitalization. Different methods including intravenous lidocaine, topical lidocaine, propofol, iv magnesium and the like have been proposed to reduce laryngospasm; different results have been obtained in studies. Thermal softening of endotracheal tubes (ETT) with normal warm saline before intubation has been shown to be significantly effective in reducing sore throat and hoarseness during recovery and postoperatively. The aim of this study was to compare the intraoperative and postoperative respiratory effects of using endotracheal intubation tubes at different temperatures during intubation in children undergoing adenotonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. Children intubated with an endotracheal tube which 24° celcius (Group T24), Children intubated with an endotracheal tube which 37° celcius (Group T37)
| Arm | Type | Receives |
|---|---|---|
| Group T24 (24°C Endotracheal tube) | Active comparator | Other: 24°C Endotracheal tubeAnesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation. |
| Group T37 (37°C Endotracheal tube) | Active comparator | Other: 37°C Endotracheal tubeAnesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents who agreed to participate in the study
- Children undergoing adenotonsillectomy
- ASA 1 and 2 class patients
Key exclusion criteria (6 listed)
- Emergency surgery
- Children with a history of difficult airway
- Children who have had upper airway surgery
- Presence or suspicion of upper or lower respiratory tract infection
- History of cardiac and respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24°C Endotracheal tubeA disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 24°C for the T1 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study. | Other | Group T24 (24°C Endotracheal tube) |
| 37°C Endotracheal tubeA disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 37°C for the T2 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study. | Other | Group T37 (37°C Endotracheal tube) |
Primary outcome
Rate of laryngospasm
Time frame: From extubation until postoperative 2. hour
The rates of laryngospasm occurring in the participants will be determined and compared between the 2 groups
Rate of bronchospasm
Time frame: From extubation until postoperative 2. hour
The rates of bronchospasm occurring in the participants will be determined and compared between the 2 groups
Rate of desaturation
Time frame: From extubation until postoperative 2. hour
The rates of desaturation occurring in the participants will be determined and compared between the 2 groups
5 secondary outcomes
Heart rate
Time frame: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Mean arterial pressure (MAP) mmHg
Time frame: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Oxygen saturation
Time frame: 7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)
Intraopearative anaesthesia machine respiratory data
Time frame: 4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)
Intraopearative anaesthesia machine respiratory data 2
Time frame: 4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)
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 15 Apr 2026.
- Background: PubMed 21634056Jeyakumar A, Fettman N, Armbrecht ES, Mitchell R. A systematic review of adenotonsillectomy as a risk factor for childhood obesity. Otolaryngol Head Neck Surg. 2011 Feb;144(2):154-8. doi: 10.1177/0194599810392328.
- Background: PubMed 22252947Orestes MI, Lander L, Verghese S, Shah RK. Incidence of laryngospasm and bronchospasm in pediatric adenotonsillectomy. Laryngoscope. 2012 Feb;122(2):425-8. doi: 10.1002/lary.22423. Epub 2012 Jan 17.
- Background: PubMed 24660159Marzban S, Haddadi S, Naghipour MR, Sayah Varg Z, Naderi Nabi B. The effect of intravenous magnesium sulfate on laryngospasm after elective adenotonsillectomy surgery in children. Anesth Pain Med. 2014 Feb 28;4(1):e15960. doi: 10.5812/aapm.15960. eCollection 2014 Feb.
- Background: PubMed 36937172Mohseni M, Farahmand Rad R, Jafarian AA, Zarisfi AH, Masoudi N. The Effect of Softening of Endotracheal Tubes on the Decrement of Postoperative Hoarseness and Sore Throat. Anesth Pain Med. 2022 Nov 15;12(5):e123910. doi: 10.5812/aapm-123910. eCollection 2022 Oct.
- Background: PubMed 36221346Yu Y, Jia Q, Zhou L, Liu Z, Liang S, Yang Z, Wan Q. Appropriate tube temperature for fiberoptic bronchoscope-guided intubation of thermally softened double-lumen endotracheal tubes: A CONSORT-compliant article. Medicine (Baltimore). 2022 Oct 7;101(40):e29999. doi: 10.1097/MD.0000000000029999.
- Background: PubMed 25468575Komasawa N, Nishihara I, Tatsumi S, Minami T. Prewarming of the i-gel facilitates successful insertion and ventilation efficacy with muscle relaxation: a randomized study. J Clin Anesth. 2014 Dec;26(8):663-7. doi: 10.1016/j.jclinane.2014.08.009. Epub 2014 Nov 18.
- Derived from this study: PubMed 42725682Dikici M, Kaciroglu A, Cevikkalp E, Aras T, Eglen MY, Alan Y, Tuzemen G, Aydogmus I, Ekinci M. Effect of Thermal Softening of Endotracheal Tubes on Perioperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy: A Randomized Controlled Trial. Paediatr Anaesth. 2026 Sep 11. doi: 10.1002/pan.70312. Online ahead of print.
- Individual participant dataSharing planned: No. The investigators will not share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24°C Endotracheal tube and 37°C Endotracheal tube in people with Adenotonsillectomy, run by Bursa City Hospital 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 6 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 15 Apr 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?
Rate of laryngospasm (time frame: From extubation until postoperative 2. hour). The study lists 3 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 NCT06838260, which also lists 7 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 15 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.