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The 90% effective dose of intranasal dexmedetomidine combined with chloral hydrate for sedation under CSI monitoring in infant hearing diagnostic test

The 90% effective dose of intranasal dexmedetomidine combined with chloral hydrate for sedation under CSI monitoring in infant hearing diagnostic test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080656
Enrollment
Unknown
Registered
2024-02-04
Start date
2024-02-18
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Sedation for diagnostic hearing examination in infants

Interventions

dexmedetomidine with chloral hydrate (biased coin sequential method):Each child will be given 50mg/kg oral solution of 10% chloral hydrate.15 minutes later ,the child will be given nasal drops at a ca
If sedation of the former child is judged successful ,there is a 10% chance that the dose of dexmedetomidine in the latter child will be reduced by a gradient and a 90% chance that the original dose w

Sponsors

Jiangmen Women's and Children's Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: (1)children who are to undergo diagnostic hearing tests and require medium deep sedation;(2)the age ranges from 1 month to 12 months;(3) ASA grade ? ~ ?.

Exclusion criteria

Exclusion criteria: (1)premature infant;(2)allergic to chloral hydrate or dexmedetomidine;(3)nasal congestion,runny nose and other upper respiratory tract infection symptoms;(4)children with severe dysplasia and weight not reaching the normal range;(5)children with severe central nervous system,respiratory,circulation,liver and kidney dysfunction and other systemic diseases;(6)the children and their parents refused to accept the test.

Design outcomes

Primary

MeasureTime frame
The 90% effective dose (ED90) of dexmedetomidine nasal drops in a compound oral solution of 50mg/kg 10% chloral hydrate for infant sedation in diagnostic examination of hearing.;

Secondary

MeasureTime frame
Ramsay sedation score;cerebral state index;systolic pressure;heart rate;pulse oxygen saturation;

Countries

China

Contacts

Public ContactWanting Li/ Haihong Deng

Jiangmen Women's and Children's Health Hospital

549777851@qq.com+86 158 1576 4149

Outcome results

None listed

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