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NCT Number: NCT05769842

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

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.

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Key information

Conditions

Airway Complication of Anesthesia

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital affiliated with Fudan University

Shanghai, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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.

Other names: No Other Intervention Names

normal saline

Drug

Same dose as propofol.

Other names: No Other Intervention Names

Primary outcomes

  1. respiratory adverse events

    Time frame: From 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:

    • 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.

Secondary outcomes

  1. extubation time

    Time frame: No 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.

  2. Richmond Agitation Sedation Scale

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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