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Study of Dexmedetomidine to relieve pre-operative anxiety in children undergoing eye surgery

Prospective randomised comparative study of two doses of intranasal dexmedetomidine for premedication in paediatric ophthalmic surgical patients - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056530
Enrollment
60
Registered
2023-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Intra nasal Dexmedetomidine dosage 0.5mcg/kg: Intra nasal Dexmedetomidine dosage 0.5mcg/kg given half an hour prior to induction for 30patients. Total duration of study is 6months

Sponsors

Nethradhama Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children for eye surgery ASA 1 & 2

Exclusion criteria

Exclusion criteria: Patient refusal, known allergy to Dexmedetomidine, Any obvious aberrant nasal deformity, acute or chronic nasal trauma that may preclude adequate intranasal delivery of drug, Patients with anticipated difficult airway and obese, Renal and liver dysfunction, cardiovascular disease including bradycardia, respiratory disease, infection, Drowsy on the day of surgery with Ramsay Level of Sedation Score >3

Design outcomes

Primary

MeasureTime frame
Comparative assessment of the effect of intra nasal dexmedetomidine pre-operatively in children undergoing eye surgery given intranasally at dose 0.25mcg/kg or 0.5mcg/kgTimepoint: 6months

Secondary

MeasureTime frame
Adverse effect associated with intranasal dexmedetomidine given at 0.25mcg/kg & 0.5mcg/kgTimepoint: 6months

Countries

India

Contacts

Public ContactDr Suman Shree Ramaswamy

Nethradhama Super speciality Eye hospital

ceo@nethradhama.org08026088120

Outcome results

None listed

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