Comparison Of Premedication With Two Different Doses Of Intranasal Atomised Dexmedetomidine In Children Undergoing Elective Surgery.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To compare the effect of premedication with two different doses of intranasal atomised dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
Study Overview
Brief Summary
The preoperative period is the most distressing for children undergoing surgery,and this is made even more so with parental separation,fear of physicians and needle injections.Preoperative anxiety stimulates sympathetic,parasympathetic and endocrine systems leading to increased heart rate,blood pressure and cardiac excitability may sometime prolong the induction of the anaesthesia. It also predisposes the children to emergence delirium,sleep disturbances and behavioural changes postoperatively.
A few methods to alleviate preoperative anxiety include appropriate preoperative communication,being accompanied by their parents during induction of anaesthesia and medical interventions i.e.,premedication. Sedative premedication is the most common and effective means to minimize preoperative anxiety,minimize emotional trauma and facilitate smooth induction of anaesthesia.Dexmedetomidine is a new highly selective alpha 2 adrenergic agonist. It provides sedation,analgesia,and anxiolysis without any respiratory depression.
In view of the above situation,we are conducting a study to compare the effect of two doses of intranasal atomized dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 1.00 Year(s) to 6.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American society of Anaesthesiologist’s grade I and grade II patients undergoing Elective surgery under general anaesthesia.
Exclusion Criteria
- •Active upper respiratory tract infection or significant organ dysfunction.
- •Patients with known allergy to study drug.
- •Patients with cardiac dysrhythmias, congenital heart disease,hemodynamic or respiratory instability or at risk for airway obstruction.
- •Patients using psychotropic medication.
Outcomes
Primary Outcomes
To compare the effect of premedication with two different doses of intranasal atomised dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
Time Frame: Primary outcome will be assessed 30 minutes after premedicating the children with intranasal atomised Dexmedetomidine.
Secondary Outcomes
- Preoperative sedation(Before taking patient for elective surgery.)
- Mask acceptance
- Recovery