Brain Diseases Clinical Trial
— DPMPOfficial title:
Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient
Verified date | July 2016 |
Source | Maharashtra University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Institutional Review Board |
Study type | Interventional |
MRI though not painful requires deep sedation for children due to the loud noise created.
With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For
standardization MRI brain was chosen and also for the fact that patients usually have
history of convulsions where drugs like ketamine may not be a good option. Patients were
recruited after ethics committee approval. After pre-medication with intranasal midazolam
0.2 mg/kg body weight, Intravenous access was established and then patients were divided in
two groups. One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg
body weight per minute. The other group received intravenous bolus of Dexmedetomidine
1mcg/kg over 10 minutes and then a infusion of Dexmedetomidine 1mcg/kg/hour.
Primary out come was to study the recovery time of patients sedated with Dexmedetomidine
compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were
analysed in terms of time for induction,procedural disruptions due to awakening and
haemodynamic stability . Follow up was done on phone for any adverse events.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 7 Years |
Eligibility |
Inclusion Criteria: - children posted for elective MRI brain - American society of anaesthesiologist physical status I and II Exclusion Criteria: - age less than 1 year and more than 7 years - American society of anaesthesiologist physical status III and IV - emergency cases - upper respiratory tract infection - patients on digoxin and beta blockers - allergy to study drugs - Body mass index more than 35 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College | Mumbai | Maharastra |
Lead Sponsor | Collaborator |
---|---|
Maharashtra University of Health Sciences |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery time | Recovery time - time from the end of the procedure till the patient achieves a Modified aldred score of 10.Modified Aldred Score- a score from 0- 10 considering 5 parameters of activity, oxygen saturation, respiration, circulation and consciousness each given score 0,1,2. Score of 10 patients can be sent home after outpatient anaesthesia. | 4 hours after procedure | No |
Secondary | Time for induction | time for induction - time from administration of drug to the patient till the patient is sedated enough for allowing positioning for MRI | One hour | No |
Secondary | Procedural disruptions due to awakening of the patient | Number of patients in each group who had one or more awakening during the procedure was compared | one hour | No |
Secondary | Bradycardia | number of patients having bradycardia after induction till recovery was compared. Bradycardia is heart rate less than 60 beats per minute | 6 hours | No |
Secondary | Desaturation | Number of patients in each group that had desaturation was compared. Desaturation was defined as drop in oxygen saturation of less than 98 percent inspite of supplemented oxygen. Normal oxygen saturation as measured by pulse oximeter is 100 percent on room air. | 6 hours | No |
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