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Optimal dose study of esketamine combined with midazolam for pediatric preoperative sedation

Optimal dose study of esketamine combined with midazolam for pediatric preoperative sedation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102423
Enrollment
Unknown
Registered
2025-05-14
Start date
2023-03-20
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Pediatric Surgery

Interventions

Group 2:0.1mg/ kg esketamine
Group 3:0.3mg/ kg esketamine
Group 1:0 mg/ kg esketamine
Group 4:0.5mg/ kg esketamine
Group 5:0.7mg/ kg esketamine

Sponsors

Linping District Women and Children Care Hospital ,Zhejiang,Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 4 Years

Inclusion criteria

Inclusion criteria: Children aged 1 to 4 years, of any sex, classified as ASA I–II, scheduled to undergo elective laparoscopic inguinal hernia repair under general anesthesia, and requiring preoperative sedation. Inclusion criteria also required a Parental Separation Anxiety Score (PSAS) of >=3 on two occasions in the preoperative holding area.(PSAS: 1 = easy separation; 2 = whimpers but easily calmed; 3 = crying and not easily calmed; 4 = crying and clinging tightly to parents).

Exclusion criteria

Exclusion criteria: Children with known allergy to midazolam, esketamine, or ketamine; those with respiratory tract infection, central nervous system dysfunction, cardiovascular dysfunction, or gastrointestinal disease; children undergoing surgery lasting >=90 minutes; obese children weighing more than 30 kg; emergency surgeries; or children whose guardians declined participation were excluded.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Preoperative Separation Anxiety Score;secretion;Respiratory depression;3-minute separation anxiety score;Surgical duration;Wake up duration;Nausea and vomiting;

Countries

China

Contacts

Public ContactSufeng Lin

Maternal and Child Health Hospital, Linping District, Hangzhou, Zhejiang Province

gubin1975@163.com+86 181 5717 8100

Outcome results

None listed

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