Dexmedetomidine Verses Propofol for Paediatric MRI Brain

Brain Diseases Clinical Trial

— DPMP  

Official title:

Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776189
• Other study ID #: iec/30/12
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2016
• Last updated: July 17, 2016
• Start date: October 2012
• Est. completion date: March 2014

Study information

• 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

Clinical Trial Summary

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.

Description:

Patients were evaluated on out patient department basis. On the day of MRI nil per oral status of 6 hours was confirmed and consent taken from the parent. In recovery room after recording of vitals, children were given intranasal midazolam 0.2mg/kg body weight. The intravenous line was secured after the child was sedated. Patients were then divided in two groups. In the MRI console, the dexmedetomidine group received intravenous dexmedetomidine 1mcg/kg body weight over 10 minutes. An intravenous infusion of dexmedetomidine was then started at 1mcg/kg/hour.

The propofol group received 2mg /kg of intravenous propofol and an infusion of 100mcg/kg/minute.

MRI monitoring included pulseoximetry, cardioscope, respiratory pattern and rate. Oxygen was delivered by nasal prongs. Primary outcome measured was the time for recovery.

Secondary outcomes were number of awakening during procedure, haemodynamic stability, induction time and any adverse events.

After MRI the children were observed in the recovery room and discharged after achieving 'modified aldred score' of 10. Vitals and any adverse events were recorded during this phase.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Drug:
• Dexmedetomidine
intravenous dexmedetomidine 1 mcg per kg body weight over 10 minutes followed by infusion of dexmedetomidine at dose of 1 mcg per kg body weight per hour till end of procedure
• propofol
intravenous propofol 2mg per kg body weight followed by infusion of propofol at a dose of 100 mcg per kg body weight per min till end of procedure
• Midazolam
Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation

Locations

Country	Name	City	State
India	Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College	Mumbai	Maharastra

Sponsors (1)

Lead Sponsor	Collaborator
Maharashtra University of Health Sciences

Country where clinical trial is conducted

India, 

Outcome

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