Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical Health Condition 3: G978- Other intraoperative and postprocedural complications and disorders of nervous system
Conditions
Interventions
Intervention1: Dexmedetomidine: For Dexmeditomedine, 3ug/kg of 100ug/ml solution, diluted upto 2 ml with sterile water.
1 ml in each nostril will be administered with the child in a recumbent position
45 minutes prior to MRI in pediatric neurosurgical patients undergoing MRI.
Control Intervention1: midazolam: For Midazolam, 0.2mg/kg of 1mg/ml solution, diluted upto 2 ml with sterile water.
1 ml in
45 minutes prior to MRI in pediatric neurosurgical patients undergoing MRI.
Sponsors
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. ASA physical status I&II patients 2. Glasgow Coma Scale 15/15
Exclusion criteria
Exclusion criteria: 1. ASA physical status III & IV 2. Active URTI/LRTI 3. Anticipated difficult airway 4. Patients with history of allergy or history of drug sensitivity 5. Patients with renal or hepatic dysfunction 6. Congenital heart disease 7. Nasal crusting/excoriations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of sedation amongst the two groups as evaluated by- - Ease of Parental Separation as assessed by Parental Separation Score - Need for additional rescue drug requirement as assessed by sedation score (University of Michigan Sedation Scale (UMSS) Scoring) - MRI Quality as assessed by MRI quality score (by radiologist) Timepoint: Baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| A) To assess following parameters in between two study groups â?¢ Occurrence of respiratory, cardiovascular adverse and other events (bradycardia, hypotension, decreased SpO2) â?¢ Time of onset and duration of sedation (in minutes) â?¢ Recovery duration (in minutes) â?¢ Ease of IV cannulation by IV cannulation score â?¢ Child response to Intranasal drug administration B) Correlation between Bi Spectral Index and UMSS C) Correlation between Bi Spectral Index and Modified Aldrete scoreTimepoint: Baseline, then every 10 minutes till 120 minutes | — |
Countries
India
Contacts
Public ContactDr Rajishth Mittal
G B PANT INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH (G.I.P.M.E.R)
Outcome results
None listed