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The Effect of Personalized Surgical Pleth Index (SPI)-Guided Analgesic Management on Postoperative Sleep Outcomes in Pediatric Surgical Patients

The Effect of Personalized Surgical Pleth Index (SPI)-Guided Analgesic Management on Postoperative Sleep Outcomes in Pediatric Surgical Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108451
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Interventions

Group S (SPI-guided group):Surgical volume area index monitoring
Group C (Control group):Routine monitoring

Sponsors

Foshan Maternity & Child Healthcare Hospital,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children undergoing elective tonsillectomy; Age 3-6 years; American Society of Anesthesiologists (ASA) grade 1~2; Normal growth and development.

Exclusion criteria

Exclusion criteria: History of respiratory tract infection 1 week before surgery; Preoperative liver and kidney insufficiency; Any congenital malformations or acquired diseases that may increase the risk of anesthesia and the dose of anesthetics (such as but not limited to congenital heart disease, hydronephrosis, malnutrition, etc.); Mental abnormalities; Long-term use of sedative or analgesic medications.

Design outcomes

Primary

MeasureTime frame
The scores of the Children's Sleep Habits Questionnaire before surgery and the day after discharge;

Secondary

MeasureTime frame
Incidence of agitation in the PACU after surgery, PAED score;Intraoperative remfentanyl dosage;Indwelling time of endotracheal tubes;Duration of surgery;PACU length of stay and adverse anesthetic reactions: laryngospasm, apnea, arrhythmia, hypotension, hypertension, and nausea and vomiting;

Countries

China

Contacts

Public ContactShe Ruixuan

Foshan Maternity & Child Healthcare Hospital,

317066802@qq.com+86 13542589149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026