To compare two drugs dexmedetomidine and midazolam as premedication in children undergoing corrective surgery for congenital heart disease .

A randomised controlled trial to compare the intranasal midazolam with intranasal dexmedetomidine as premedication on sedation level and separation anxiety in children undergoing corrective surgery for congenital heart disease .

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011297

Enrollment

Registered

2018-01-12

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: null- Congenital heart disease Health Condition 2: Q249- Congenital malformation of heart,unspecified

Interventions

Intervention1: Pre anaesthetic medication: comperision of two common preanaesthetic agents Control Intervention1: Midazolam: Distress especially due to maternal separation is undesirable in these pati

Eligibility

Inclusion criteria

Inclusion criteria: congenital heart disease paediatric patients within 2 to 12 years age planned for corrective open heart surgery

Exclusion criteria

Exclusion criteria: 1. Patients undergoing palliative surgeries. 2. Child with developmental delay and/or with neurological disease (Cerebral palsy, Raised ICP etc. 3. Hepatic or renal complication , 4. Conduction disorders,coronary artery disease, 5. Allergy to benzodiazepines or alpha 2 receptor agonist drugs.

Design outcomes

Primary

Measure	Time frame
1. To compare the effect of intranasal dexmedetomidine and intranasal midazolam on sedation level and on separation anxiety from parents in children undergoing corrective surgery for congenital heart disease .Timepoint: 30 min	—

Secondary

Measure	Time frame
2. To compare the effect of intranasal dexmedetomidine and intranasal midazolam on mask acceptance during induction in operation room .3.. To compare the haemodynamic effect of intranasal dexmedetomidine and intranasal midazolam and to bring out the difference if any.Timepoint: 30 min	—

Countries

India

Contacts

Public ContactRakesh Sharma

Armed forces medical college,pune

rjv.nr1@gmail.com7757024594

Outcome results

None listed

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