Skip to content

Examination of children with glaucoma using a new modality for sedation

Evaluation of Intranasal Dexmedetomidine as a sedative agent for examination of children with pediatric glaucoma without inhalational anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017274
Enrollment
60
Registered
2019-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Dexmedetomidine: Intranasal Dexmedetomidine 3.5ug/kg administered by an atomizer and examination started after 20 minutes. Maximum time to wait for effect will be 45 minutes. Control In

Sponsors

Medical Education Cell Postgraduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children with age of 6 months to years requiring Examination under sedation following surgery for pediatric glaucoma. 2) ASA (American Society of Anaesthesiologists) physical status I/II

Exclusion criteria

Exclusion criteria: Cardiorespiratory distress bradycardia upper respiratory tract infection liver disease seizures acute medical condition

Design outcomes

Primary

MeasureTime frame
Percentage of children having successful examination without requiring rescue sedative agent at 30minutes after intranasal dexmedetomidineTimepoint: 30 minutes after intranasal dexmedetomidine

Secondary

MeasureTime frame
1.Mean time of onset of adequate sedation score (Ramsayâ??s score) 2.Sedation scores at 10 minutes, 20 minutes and 30 minutes after administration 3.Need of rescue drug if no sedation after 30 minutes 4. Surgeon satisfaction score for completion of procedure (IOP, Corneal diameter, ophthalmoscopy) 5. Discharge time 6. Adverse effects 7. Parents satisfaction Timepoint: Sedation score will be assessed at 10, 20 and 30 minutes after administration of the drug.

Countries

India

Contacts

Public ContactSushmita Kaushik

Advanced Eye Centre, Postgraduate Institute of Medical Education & Research

sushmita_kaushik@yahoo.com09814813207

Outcome results

None listed

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