Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy

Bursa City Hospital

Status: Enrolling

Conditions: Adenotonsillectomy

Treatments: Other: 24°C Endotracheal tube; Other: 37°C Endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06838260

Bursa City Hospital 11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parents who agreed to participate in the study
• Children undergoing adenotonsillectomy
• ASA 1 and 2 class patients

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Group T24 (24°C Endotracheal tube)

Active Comparator group

Description:

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.

Treatment:

Other: 24°C Endotracheal tube

Group T37 (37°C Endotracheal tube)

Active Comparator group

Description:

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.

Treatment:

Other: 37°C Endotracheal tube