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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05769842
Enrollment
239
Registered
2023-03-15
Start date
2023-11-01
Completion date
2024-01-01
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia

Keywords

propofol, tracheal extubation, respiratory adverse events

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.

Interventions

DRUGpropofol

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.

DRUGnormal saline

Same dose as propofol.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
respiratory adverse eventsFrom the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.These include six items in total: 1. laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief . 2. bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation. 3. breath-holding:no breathing time \> 5 seconds or more. 4. cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough. 5. low oxygen saturation:less than 92% on oxygen. 6. respiratory obstruction:jaw support is needed for relief.

Secondary

MeasureTime frameDescription
extubation timeNo more than three hours from the end of the procedure until the tracheal tube was pulled out.longer than 15 minutes means longer extubation time.
Richmond Agitation Sedation ScaleFrom the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026