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The study of oral midazolam combined with transnasal dexmedetomidine in pediatric perioperative period: A Randomized Controlled Trial

The study of oral midazolam combined with transnasal dexmedetomidine in pediatric perioperative period: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081634
Enrollment
Unknown
Registered
2024-03-07
Start date
2024-03-26
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Inguinal hernia and hydrocele in children

Interventions

Oral midazolam 1mg/kg+nasal saline group:Oral administration of midazolam 1mg/kg+nasal drip of physiological saline 0.01ml/kg
Oral midazolam 0.5mg/kg+nasal dexmedetomidine 1ug/kg group :Oral midazolam 0.5mg/kg+nasal dexmedetomidine 1ug/kg
Oral midazolam 1mg/kg+nasal dexmedetomidine 1ug/kg group:Oral midazolam 1mg/kg+nasal dexmedetomidine 1ug/kg

Sponsors

The Sixth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: (1) Age: 2-6 years old; (2) ASA classification levels I-II; (3) Children with a weight<30kg (4) Who undergo laparoscopic surgery under elective sevoflurane general anesthesia require preoperative sedation; (5) Sign an informed consent form to confirm voluntary participation in this study in accordance with relevant rules.

Exclusion criteria

Exclusion criteria: (1) Known to have a history of allergies to medications used during surgery; (2) Recent history of upper respiratory tract infection; (3) Patients with nasal cavity lesions; (4) Individuals with central system diseases; (5) Individuals with cardiovascular disease or severe liver or kidney dysfunction; (6) Parents refuse.

Design outcomes

Primary

MeasureTime frame
Pediatric Anesthesia Emergence Delirium, PAED;

Secondary

MeasureTime frame
Ramsay Sedation Score, RSS;Modified Yale Preoperative Anxiety Scale, mYPAS;Parental Separation Anxiety Scale, PSAS;Mask Acceptance Scale, MAS;awakening time ;natural awakening time;FLACC pain;

Countries

China

Contacts

Public ContactWanchao Yang; Qingbo Cui

The Sixth Affiliated Hospital of Harbin Medical University

dachao_1980@126.com+86 137 9663 6010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026