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Comparing the effects of atomised(intranasal aerosol) and nebulised (respiratory)droplets forms of dexmedetomidine to sedate children of upto 8 years of age undergoing cataract surgery

Comparison of Atomised vs Nebulised Dexmedetomidine for premedication in children upto 8 years undergoing cataract surgery

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017671
Enrollment
170
Registered
2019-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: H25-H28- Disorders of lens

Interventions

Intervention1: Group A: Group A - will receive intranasal dexmedetomidine in doses of 2.5 µg/kg through mucosal atomised device in both the nostrils (single administration) about 30 minutes prior

Sponsors

Ankur Luthra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA I and II children aged 1 to 8 years scheduled for cataract surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Children with cardiac anomalies, upper respiratory tract infection, liver disease, seizures or an acute medical condition, increased intracranial pressure, or a history of dexmedetomidine allergy will be excluded.

Design outcomes

Primary

MeasureTime frame
Comparison of effectiveness of atomised vs nebulised dexmedetomidine as pre-medication in children undergoing cataract surgery in terms of parental separation score Emotional State Scale-4.Timepoint: 30 min after intervention

Secondary

MeasureTime frame
To Compare 1. Mean time of onset of adequate sedation score 2. Success rate of IV cannulation 3. Parental separation 4. Mask acceptance 5. Haemodynamic changes 6. Wake up behaviour Timepoint: 30 min after intervention

Countries

India

Contacts

Public ContactAnkur Luthra

Post Graduate Institute of Medical Education and Research, Chandigarh

zazzydude979@gmail.com01722756500

Outcome results

None listed

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