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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Airway Complication of Anesthesia

Intervention / Treatment
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* Drug: propofol
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol group<br>Children aged 3 to 8 years who had had their tonsil adenoidectomy were collected. Propofol 3mg/kg, remifentanil 3-5ug /kg and atropine 0.01mg/kg were used for intravenous induction intubation. Sevoflurane was used for intraoperative anesthesia, propartamol 30mg/kg and hydromorphone 5-10ug /kg were used for postoperative analgesia.When sevoflurane was shut down at the end of the operation, oxygen flow was increased to more than 7L/min, and extubation was prepared for spontaneous respiration recovery, propofol was given a small amount of 1 2mg/kg multiple times without inhibition of spontaneous respiration. | Drug: propofol<br>* 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.<br>* Other names: No Other Intervention Names;|
| Sham Comparator: control group<br>Anesthesia induction is the same as before.At the end of the operation, sevoflurane was shut down and oxygen flow was increased to more than 7L/min. No other treatment was performed during extubation. | Drug: normal saline<br>* Same dose as propofol.<br>* Other names: No Other Intervention Names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, tracheal extubation, respiratory adverse events