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Effect of Intranasal Dexmedetomidine or Oral Midazolam Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children.

The Effect of Intranasal Dexmedetomidine or Oral Midazolam Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children. A comparative study

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003438
Enrollment
56
Registered
2013-02-28
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: null- Any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion

Interventions

Intervention1: Group M received 0.5 mg/Kg oral midazolam and intranasal saline, group D received 2µg/Kg intranasal dexmedetomidine along with oral honey 20-30min before procedure.: EC 50 for LMA ins

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and 2 patients of either gender of the age 1- 6 years undergoing any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion

Exclusion criteria

Exclusion criteria: airway malformations, clinical evidence of patients with difficult airway, asthma or any sign of upper respiratory tract infection, G6PD deficiency, organ dysfunction , allergy or hypersensitive reaction to dexmedetomidine , known cardiac arrhythmia or congenital heart disease, mentally disabled , known case of autism or developmental pervasive disorder or failure to insert LMA.

Design outcomes

Primary

MeasureTime frame
To determine and compare the EC50 of sevoflurane for LMA insertion in children in all the three groupsTimepoint: At or one minute after LMA insertion

Secondary

MeasureTime frame
Ramsay Sedation Score, parental separation score, induction score success rate, and the incidence of adverse eventsTimepoint: Ramsay sedation score at baseline, 15 and 30 minutes after premedication, parental separation score at taking the child in the OT and induction score at placing the face mask, adverse events at or one minute after LMA insretion

Countries

India

Contacts

Public ContactDr Babita Ghai

Post Graduate Institute of Medical Education and Research, Chandigarh

rani.jyothi5@gmail.com9855558494

Outcome results

None listed

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