Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy

Airway Complication of Anesthesia Clinical Trial

Official title:

Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769842
• Other study ID #: 2022-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.

Description:

In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• age: 3~8 years old,
• general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
• the operation time is 10~60 minutes,
• sign informed consent.

Exclusion Criteria:

• patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
• children who do not consent to the test.

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Drug:
• propofol
Propofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1~2mg/kg before extubation when the patient recovered spontaneously.
• normal saline
Same dose as propofol.

Locations

Country	Name	City	State
China	Children's Hospital affiliated with Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27. — View Citation

Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Inhalational versus IV induction of anesthesia in children with a high risk of perioperative respiratory adverse events. Anesthesiology. 2018;128(6):1065-1074. AORN J. 2018 Nov;108(5):566-571. doi: 10.1002/aorn.12390. No abstract available. — View Citation

von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Sep;30(9):529-36. doi: 10.1097/EJA.0b013e32835df608. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory adverse events	These include six items in total: laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief .; bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation.; breath-holding:no breathing time > 5 seconds or more.; cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough.; low oxygen saturation:less than 92% on oxygen.; respiratory obstruction:jaw support is needed for relief.	From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
Secondary	extubation time	longer than 15 minutes means longer extubation time.	No more than three hours from the end of the procedure until the tracheal tube was pulled out.
Secondary	Richmond Agitation Sedation Scale	The score ranges from -5 to +4. A higher score indicates more agitation and a lower score indicates greater calmness. In this study, a score greater than or equal to 1 indicates agitation.	From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.