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Effective dose of intranasal dexmedetomidine for struggle free induction of anaesthesia in children with retinoblastoma undergoing examination under anaesthesia

: Median effective dose of intranasal dexmedetomidine for satisfactory mask induction in children undergoing examination under anaesthesia for retinoblastoma- an up and down sequential allocation study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031258
Enrollment
40
Registered
2021-02-12
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: C692- Malignant neoplasm of retina

Interventions

Intervention1: Intranasal Dexmedetomidine: Dixon up and down methodology is a sequential allocation method to determine the median effective dose of a drug to achieve a selected end point. a first dos

Sponsors

Narayana Nethralaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 40 ASA I-III children with known or suspected retinoblastoma aged 1-60 months undergoing EUA ± focal therapy

Exclusion criteria

Exclusion criteria: The exclusion criteria are lack of parental consent, known allergy to dexmedtomidine, nasal discharge, renal or hepatic dysfunction, any serious systemic diseases

Design outcomes

Primary

MeasureTime frame
The primary outcome is to determine the 50% effective dose and estimate the 95% effective dose of intranasal dexmedetomidine to achieve satisfactory mask acceptance The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction. Timepoint: baseline, 1 min, 5 min, 10 min and every 10 min till end of procedure—

Secondary

MeasureTime frame
The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction.Timepoint: At baseline,induction, 1 minute, every 5 minutes till the end of the procedure, recovery from anaesthesia—

Countries

India

Contacts

Public ContactShalini Subramanian

Narayana nethralaya

drshalinisubramanian@gmail.com

Outcome results

None listed

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