A clinical trial to compare effect of two drugs, intranasal dexmedetomidine and intranasal midazolam in pediatric neurosurgical patients undergoing magnetic resonance imaging.
Phase 3
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: O- Medical and SurgicalHealth Condition 3: G978- Other intraoperative and postprocedural complications and disorders of nervous system
- Registration Number
- CTRI/2021/12/038353
- Lead Sponsor
- Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. ASA physical status I&II patients
2. Glasgow Coma Scale 15/15
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of sedation amongst the two groups as evaluated by- <br/ ><br>- Ease of Parental Separation as assessed by Parental Separation Score <br/ ><br> <br/ ><br>- Need for additional rescue drug requirement as assessed by sedation score <br/ ><br>(University of Michigan Sedation Scale (UMSS) Scoring) <br/ ><br>- MRI Quality as assessed by MRI quality score (by radiologist) <br/ ><br>Timepoint: Baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes
- Secondary Outcome Measures
Name Time Method A) To assess following parameters in between two study groups <br/ ><br>â?¢ Occurrence of respiratory, cardiovascular adverse and other events (bradycardia, <br/ ><br>hypotension, decreased SpO2) <br/ ><br>â?¢ Time of onset and duration of sedation (in minutes) <br/ ><br>â?¢ Recovery duration (in minutes) <br/ ><br>â?¢ Ease of IV cannulation by IV cannulation score <br/ ><br>â?¢ Child response to Intranasal drug administration <br/ ><br>B) Correlation between Bi Spectral Index and UMSS <br/ ><br>C) Correlation between Bi Spectral Index and Modified Aldrete scoreTimepoint: Baseline, then every 10 minutes till 120 minutes <br/ ><br>