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
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/05/042482
- Lead Sponsor
- AIIMS Raipur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
2 to 12 yrs
Infraumbilical surgeries under GA
Parents of children who give consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety status measured by Modified Yale Preoperative Anxiety score <br/ ><br>Vitals ââ?¬â?? HR, RR, MAP, SpO2Timepoint: At baseline, every 5 min for 30 min preoperative, postoperative period
- Secondary Outcome Measures
Name Time Method Sedation status measured by University of Michigan Sedation scale <br/ ><br>Child parent separation score <br/ ><br>Child compliance with mask <br/ ><br>Postoperative behaviour scoreTimepoint: Preoperative 30 min after giving drug, immediate postopertive period