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Effect of esketamine on postoperative delirium and postoperative behavioral changes in children undergoing ambulatory surgery: a randomized controlled trial

Effect of esketamine on postoperative delirium and postoperative behavioral changes in children undergoing ambulatory surgery: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075918
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-09-25
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Postoperative delirium

Interventions

The intervention group:Single intravenous injection of esketamine 0.25 mg/kg 30 minutes before the end of surgery
The Control group:Single intravenous injection of isochoric saline minutes before the end of surgery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) Age: 2-7 years old children (2) Perform ambulatory surgery (3)ASA I-II (4)Maintenance of anesthesia with total inhalation anesthesia.

Exclusion criteria

Exclusion criteria: (1) Psychological or neurological disorders (2) the history of upper respiratory tract infections recently (3) Allergic reactions to esketamine and other medications used in this study (4) Inability to cooperate with the study for any reason or in the opinion of the investigator, should not be included in this trial.

Design outcomes

Primary

MeasureTime frame
Incidence of Emergence delirium;

Secondary

MeasureTime frame
PAED score at 0, 10, 20, and 30 minutes after extubation;Pain scores at 0, 10, 20, and 30 minutes after extubation;extubation time;the time eye opening;PACU stay time;The incidence of postoperative nausea and vomiting;Incidence of postoperative respiratory adverse events;satisfaction score of Parents;the occurrence of negative behavioral changes;

Countries

China

Contacts

Public ContactZhang Lu

West China Hospital, Sichuan University

304022514@qq.com+86 181 0801 1867

Outcome results

None listed

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