Health Condition 1: R400- Somnolence Health Condition 2: G409- Epilepsy, unspecified Health Condition 3: Z018- Encounter for other specified special examinations Health Condition 4: R001- Bradycardia, unspecified Health Condition 5: T444- Poisoning by, adverse effect of and underdosing of predominantly alpha-adrenoreceptor agonists
Conditions
Interventions
Control Intervention1: GROUP A: 2MCG/KG Intranasal
Dexmedetomidine
: GROUP A: 2MCG/KG Intranasal Dexmedetomidine
Administered 30-45 Mins Prior to MRI via Intranasal Route
Control Intervention2: GROUP
Sponsors
DR BHAKTI GHUDE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Paediatric patients aged 3-15years scheduled for magnetic resonance imaging. 2. ASA grade I and II patients. 3. Patients receiving intranasal dexmedetomidine as a part of routine premedication. 4. Parents providing informed consent.
Exclusion criteria
Exclusion criteria: . Parent/ guardian not willing to give consent. 2. Patients not receiving intranasal dexmedetomidine for premedication. 3. Patient with known allergic reactions to dexmedetomidine. 4. Patients with nasal pathologies like nasal septal abnormalities, nasal trauma, epistaxis, allergic rhinitis, nasal polyps and infections of upper respiratory tract. 5. Children requiring MRI on emergency basis. 6. Children with body mass index less than 18 and more than 28. 7. Patient with mental retardations, cerebral palsy, autism, uncorrected congenital heart disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sedation score assessed using the University of Michigan Sedation Scale(UMSS) The scoring system was as follows: 0 = Awake and alert 1 = Minimally sedated 2 = Moderately sedated 3 = Deeply sedated 4 = Unarousable Satisfactory sedation was defined as a UMSS score of 3 or more. Timepoint: During MRI procedure (30-45 minutes post drug administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Parental separation score o 1 = Calm o 2 = Anxious but reassurable o 3 = Anxious o 4 = Crying or resisting o Satisfactory parental separation was defined as a score of 2 or less Timepoint: at baseline;Mask acceptance score o 1 = Excellent o 2 = Good o 3 = Fair o 4 = Poor o Satisfactory mask acceptance was defined as a score of 2 or less Timepoint: at baseline;Rescue sedation requirement o Requirement of additional sedative medication due to inadequate sedation or excessive movement during MRI Timepoint: at 10mins,20mins,30mins, 40mins,50mins,60mins;MRI completion success o Successful completion of MRI without interruption or repeat scanning Timepoint: at 10mins, 20 mins,30mins,40 mins,50 mins,60 mins;Hemodynamic parameters o Heart rate o Blood pressure o Respiratory rate o Oxygen saturation Timepoint: at baseline,10mins, 20 mins,30mins,40 mins,50 mins,60 mins;Adverse events o Bradycardia o Hypotension o Respiratory depression o Oxygen desaturation Timepoint: at baseline,10mins, 20 mins,30mins,40 mins,50 mins,60 mins | — |
Countries
India
Contacts
Public ContactDR Bhakti Ghude
Lokmanya Tilak Municipal Medical College and Hospital
Outcome results
None listed