Lateral Positioning for Extubation After Adenotonsillectomy

Sichuan University

Status: Not yet enrolling

Conditions: Adenoidectomy; Children; Tonsillectomy; Perioperative Respiratory Adverse Events

Treatments: Procedure: lateral postion; Procedure: supine position

Study type: Interventional

Funder types: Other

Identifiers

NCT07108218

2025HX880

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

lateral position group

Experimental group

Description:

In the experimental group, the children will be placed in a head-up 30° lateral position for tracheal extubation and observation at the end of the procedure.

Treatment:

Procedure: lateral postion

the supine position group

Placebo Comparator group

Description:

In the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure.

Treatment:

Procedure: supine position