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A randomized controlled study of dexmedetomidine combined with midazolam nasal drops for CT examination in infants

A randomized controlled study of dexmedetomidine combined with midazolam nasal drops for CT examination in infants

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049122
Enrollment
Unknown
Registered
2021-07-21
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

cleft palate

Interventions

DM group:Dexmedetomidine combined with midazolam nasal drops

Sponsors

Peking University of Stomatllogical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.5 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-II level; 2. Aged 1-12 months; 3. Children undergoing elective oral and maxillofacial surgery cleft palate repair with pre-CT examination.

Exclusion criteria

Exclusion criteria: 1.Congenital heart disease; 2.Atrioventricular block of degree II and above; 3.Recent upper respiratory tract infection, pneumonia or asthma attack within 2 weeks; 4.Gastroesophageal reflux disease needs treatment; 5.Recently taken digoxin, ß blockers, a2 agonists, anticonvulsants and antipsychotic drugs; 6.Allergy to a2 receptor agonists and benzodiazepines; 7.Sleep apnea, difficult airway or need for tracheal intubation or laryngeal mask ventilation; 8.Weight>25kg; 9.The inspection time is estimated to be >90 minutes.

Design outcomes

Primary

MeasureTime frame
Ramsay Sedation Scale;Sedation success rate;

Secondary

MeasureTime frame
The child's basic vital signs;Onset of sedation time;Duration of sedation;Awake time;Computed tomography time;Parent satisfaction rating;Check quality of computed tomography;

Countries

China

Contacts

Public ContactHan Fang

Peking University of Stomatological Hospital

hanfang2012jiajia@163.com+86 18611199065

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026