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

Children's Hospital of Fudan University239 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

239

Conditions

Airway Complication of Anesthesia

Interventions

propofolDRUG

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 salineDRUG

Same dose as propofol.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital affiliated with Fudan University

Shanghai, China

Outcomes

Primary Outcomes

respiratory adverse events

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.

Time frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.

Secondary Outcomes

extubation time

longer than 15 minutes means longer extubation time.

Time frame: 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.

Time frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.

Data from ClinicalTrials.gov

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