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NCT Number: NCT07108218

Lateral Positioning for Extubation After Adenotonsillectomy

The postoperative recovery period following general anesthesia has been associated with a 30%-50% incidence of postoperative respiratory adverse events (PRAEs) in pediatric populations, including laryngospasm, airway obstruction, and hypoxemia. Despite the limited effects of existing pharmacological and operative interventions, positional optimization (e.g., lateral or semirecumbent position) may play a potential role by decreasing airway resistance and improving oxygenation. However, evidence-based evidence for its use in pediatric populations is still lacking, necessitating the urgent need for randomized controlled trials.

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Key information

Conditions

Perioperative Respiratory Adverse Events Adenoidectomy Children Tonsillectomy

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study is a multi-center, prospective, RCT conducted at four tertiary hospitals in China. It will be planned to include 350 subjects who meet the inclusion criteria and will be randomly divided into the lateral position and supine position group in a 1:1 ratio by the method of block group randomization stratified by centers. In the supine position group, the children will be extubated at the end of the procedure and observed in the decubitus position until the patient's Aldrete score was >9 and they left the PACU, whereas in the lateral position group, the children will be extubated and observed in the head-up 30° lateral position. The primary outcome is the incidence of PRAEs. Secondary outcomes included frequency of PRAE, number of airway devices used during the postoperative recovery period, time to tracheal extubation, length of stay in the recovery room, and incidence of PRAE at 24 hours and 7 days. postoperatively. Safety outcomes include the incidence of peripheral IV access dislodgement, monitoring device detachment rate, and patient falls rate. Exploratory outcomes comprise pain levels (assessed via the FLACC scale), agitation scores (PAED scale), sedation scores (Ramsay scale), and PONV scores, all evaluated at postoperative extubation and PACU discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects aged 1-6 years old without gender limit.
  • Scheduled for an ambulatory adenotonsillectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) classification grade I or II.
  • Informed consent obtained from the patients' parents or legal guardians, who have expressed willingness to cooperate.

Exclusion criteria

  • Presence of concomitant cardiac or pulmonary dysfunction or other significant systemic comorbidities.
  • History of difficult airway management or congenital/acquired structural anomalies of the airway.
  • Active respiratory tract infection within 30 days preceding surgery.
  • Preoperative neurological disorders or developmental abnormalities.
  • Intraoperative occurrence of major complications necessitating deviation from the planned anesthesia protocol or surgical procedure.

Treatment and study plan

lateral postion

Procedure

The children will be positioned on their sides with their heads elevated by 30°, a thin pillow behind their backs, the upper legs bent, and the lower legs straightened.

Supine position

Procedure

The children will be changed to a supine flat-lying position for extubation.

Primary outcomes

  1. the occurrence of postoperative respiratory adverse events (PRAEs)

    Time frame: during PACU

    PRAEs include a diverse array of respiratory complications, including laryngospasm, bronchospasm, apnea, airway obstruction, stridor, cough/choking, hypoxemia.

Secondary outcomes

  1. Frequency of PRAEs

    Time frame: during PACU

    Frequency of PRAEs: Record the category and count of each PRAE occurring in each child.

  2. Number of Emergency Airway Interventions

    Time frame: during PACU

    Number of Emergency Airway Interventions: including verbal stimulation, abdominal comparession, jaw thrust, mask ventilation, rescue intubation, etc

  3. Tracheal extubation time

    Time frame: during PACU

    Tracheal extubation time: From the time the patient is transferred to the PACU until the intubation is removed. Extubation criteria: spontaneous breathing recovery and spontaneous eye opening.

  4. PACU stay duration

    Time frame: during PACU

    PACU stay duration: time from PACU admission until meeting PACU discharge criteria(*Aldrete score ≥9/10)

  5. Length of hospital stay

    Time frame: postoperative day 1

    Length of hospital stay

  6. The PRAEs at 24 hours after surgery

    Time frame: at 24 hours postoperatively

    The PRAEs at 24 hours after surgery include laryngospasm, bronchospasm, airway obstruction, stridor, cough/choking, hypoxemia, upper respiratory tract infection and pulmonary infection.

  7. The PRAEs at 7 days after surgery

    Time frame: at 7 days postoperatively

    The PRAEs at 7 days postoperatively include laryngospasm, bronchospasm, airway obstruction, stridor, cough/choking, hypoxemia, upper respiratory tract infection and pulmonary infection.

Other outcomes

  1. Adverse events

    Time frame: during PACU

    Adverse events include the incidence of peripheral intravenous access dislodgment, monitoring device detachment rate, and the rate of bed falls. Other adverse events including hypertension, hypotension, tachycardia, bradycardia, arrhythmias are also recorded.

  2. Pain score

    Time frame: every 10 minutes after extubation, when leaving the PACU.

    Pain levels are evaluated using the FLACC scale. The scale has 5 categories (face, legs, activity, cry, consolability). Each category is scored on the 0-2 scale, which results in a total score of 0-10 (0=relaxed and comfortable; 1-3=mild discomfort; 4-6 = moderate pain; 7-10 = sever discomfort or pain or both).

  3. Emergence agitation

    Time frame: every 10 minutes after extubation, when leaving the PACU.

    Emergence agitation are evaluated using the PAED scale defined as a score ≥10.

  4. Sedation scores

    Time frame: every 10 minutes after extubation, when leaving the PACU.

    Sedation scores are evaluated using the Ramsay scale. The Ramsay sedation score with scores of 1(irritability), 2(consciousness and cooperative), 3(deeper sleep and more agile response), 4(lighter sleep with faster awakening time), 5(sound sleep with slow response), and 6(no response) points, respectively.

  5. Postoperative nausea and vomiting (PONV)

    Time frame: every 10 minutes after extubation, when leaving the PACU.

    The assessment of postoperative nausea and vomiting (PONV) involves observing and inquiring about the presence of nausea, vomiting, or retching in the child.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Liang, PhD

CONTACT

[email protected]

18980602201

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

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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