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Effect of Sodium Oxybate on Pediatric Emergence Agitation

Effect of Sodium Oxybate on Pediatric Emergence Agitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125773
Enrollment
Unknown
Registered
2026-05-31
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

None

Interventions

Control group:An equal volume of normal saline was infused instead.

Sponsors

Shengjing Hospital, China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 3–14 years; 2.Scheduled to undergo elective surgery under general anesthesia; 3.Expected duration of surgery of 1 hour or longer; 4.American Society of Anesthesiologists (ASA) physical status I or II; 5.Voluntary signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows: 1.Developmental disabilities, history of neurological diseases or psychiatric disorders; 2.Severe cardiopulmonary dysfunction; hepatic or renal dysfunction; endocrine dysfunction; 3.Respiratory tract infection within one week; 4.Experienced significant stress or major life events within one month (e.g., parental divorce, other trauma or illness, etc.); 5.Patients expected to require postoperative admission to the ICU; 6.Known allergy to the active ingredient of sodium oxybate injection, or presence of contraindications to sodium oxybate use, such as hypokalemia, ethanol intoxication, or severe cardiac dysfunction, etc.

Design outcomes

Primary

MeasureTime frame
Pediatric Anesthesia Emergence Delirium(PAED) score for emergence agitation;Cornell Assessment of Pediatric Delirium(C-CAPD) Score for Postoperative Delirium;

Secondary

MeasureTime frame
FLACC Pain Scale Score for Assessment;Pediatric Scale for Quality of Recovery,PedSQoR;Self-Rating Sleep Scale Score for Sleep Quality;Children's Modified Yale Preoperative Anxiety Scale(CM-YPAS)for Anxiety;Perioperative Respiratory Adverse Events;Ramsay Score;Mask Acceptance Scale (MAS) for evaluating tolerance to facemask induction;Induction Compliance Checklist (ICC);Richmond Agitation-Sedation Scale;Postoperative inflammatory markers(IL-6,CRP);

Countries

China

Contacts

Public ContactPing Zhao

Shengjing Hospital of China Medical University

zhaoping_sj@163.com+86 24 9661 5686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026