Clinical trial NCT05769842: Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy
Official title: Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complication of Anesthesia
Keywords: propofol
tracheal extubation
respiratory adverse events
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 239
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pediatric patients were randomly assigned to either the propofol group or the control group. In the propofol group, after the child regained spontaneous breathing before extubation, propofol was administered in small repeated doses, each dose being 0.5mg/kg, with a total amount of 1\~2mg/kg. The control group received an equivalent volume of normal saline. The occurrence of respiratory adverse events (such as laryngospasm, bronchospasm, breath-holding, coughing, decreased oxygen saturation, and airway obstruction) was observed in both groups post-extubation, with the presence of any one or more events considered indicative of respiratory adverse events.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: respiratory adverse events
timeFrame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
Secondary outcomes:
measure: extubation time
timeFrame: No more than three hours from the end of the procedure until the tracheal tube was pulled out.
measure: Richmond Agitation Sedation Scale
timeFrame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital affiliated with Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Zhijian Zhou
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.