Skip to content

To evaluate the anxiolytic and sedative properties of dexmedetomidine and midazolam given intranasally in children of 2 - 12 years undergoing infraumbilical surgeries under general anaesthesia

Double blind randomised control study of intranasal Dexmedetomidine versus intranasal Midazolam as anxiolysis prior to elective infraumbilical surgeries under General Anaesthesia in Children Of age 2-12 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042482
Enrollment
90
Registered
2022-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Control Intervention1: Intranasal midaz Intranasal dexmeditomidine Intranasal saline: Comparing intranasal midazolam 0.3mg/kg,intranasal dexmeditomidine 1mcg/kg,intranasal normal saline as anxiolysis

Sponsors

AIIMS Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2 to 12 yrs Infraumbilical surgeries under GA Parents of children who give consent

Exclusion criteria

Exclusion criteria: History of allergy/contraindications to dexmedetomidine and midazolam Recent use of digoxin, beta blockers, sedatives, anticonvulsants, alpha 2 adrenergic agonists Obvious Nasal mass Recent respiratory tract infections History of bronchial asthma Children with congenital craniofacial syndromes Children with psychological disorders, developmental delay Children with possibility of difficult ventilation and intubation Children undergoing emergency surgery

Design outcomes

Primary

MeasureTime frame
Anxiety status measured by Modified Yale Preoperative Anxiety score Vitals ââ?¬â?? HR, RR, MAP, SpO2Timepoint: At baseline, every 5 min for 30 min preoperative, postoperative period

Secondary

MeasureTime frame
Sedation status measured by University of Michigan Sedation scale Child parent separation score Child compliance with mask Postoperative behaviour scoreTimepoint: Preoperative 30 min after giving drug, immediate postopertive period

Countries

India

Contacts

Public ContactSwetha G

AIIMS RAIPUR

subratsingh@gmail.com8518881767

Outcome results

None listed

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