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A dose-finding study of effective doses of remimazolam for preventing delirium after sevoflurane anesthesia in children using biased-coin design up-and-down sequential method

A dose-finding study of effective doses of remimazolam for preventing delirium after sevoflurane anesthesia in children using biased-coin design up-and-down sequential method

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104472
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Inguinal hernia

Interventions

Remimazolam group:remimazolam for preventing delirium after sevoflurane anesthesia in children

Sponsors

Shanghai Children's Medical Center, Guizhou Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 Aged 2 to 12 years, 2 No gender limit, 3 ASA I ~ II, 4 Children who are scheduled to undergo elective laparoscopic inguinal hernia repair under general anesthesia and whose guardians have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1 Under 2 years old or over 12 years old, 2 ASA was >= III, 3 The patient was complicated with difficult airway, 4 The patient was complicated with neuromuscular disease or congenital heart disease, 5 Severe hepatic or nephritic damage, 6 The patients and their guardians declined to participate in the trial.

Design outcomes

Primary

MeasureTime frame
The ED90 of remimazolam for preventing delirium after sevoflurane anesthesia in children;

Secondary

MeasureTime frame
Extubation time;The length of stay at PACU;Vital signs;Anaphylaxis;Hypoxia;Bradycardia;Hypotension;Postoperative nausea and vomiting;

Countries

China

Contacts

Public ContactZhang Ruidong

Shanghai Children's Medical Center, Guizhou Hospital, Shanghai Jiaotong University School of Medicine

doctorruidong@163.com+86 189 1663 7626

Outcome results

None listed

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