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Dexmedetomidine Verses Propofol for Paediatric MRI Brain (DPMP)

Primary Purpose

Brain Diseases

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Dexmedetomidine
propofol
Midazolam
Sponsored by
Maharashtra University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Diseases focused on measuring Anaesthesia, MRI, Brain

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Midazolam & Dexmedetomidine

Midazolam & Propofol

Arm Description

Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation. 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

Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation. Intravenous propofol 2 mg 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Bradycardia
number of patients having bradycardia after induction till recovery was compared. Bradycardia is heart rate less than 60 beats per minute
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.

Full Information

First Posted
May 11, 2016
Last Updated
July 17, 2016
Sponsor
Maharashtra University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02776189
Brief Title
Dexmedetomidine Verses Propofol for Paediatric MRI Brain
Acronym
DPMP
Official Title
Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharashtra University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases
Keywords
Anaesthesia, MRI, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midazolam & Dexmedetomidine
Arm Type
Experimental
Arm Description
Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation. 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
Arm Title
Midazolam & Propofol
Arm Type
Active Comparator
Arm Description
Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation. Intravenous propofol 2 mg 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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexem
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
propoven, diprivan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed, Fulsed
Intervention Description
Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation
Primary Outcome Measure Information:
Title
Recovery time
Description
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.
Time Frame
4 hours after procedure
Secondary Outcome Measure Information:
Title
Time for induction
Description
time for induction - time from administration of drug to the patient till the patient is sedated enough for allowing positioning for MRI
Time Frame
One hour
Title
Procedural disruptions due to awakening of the patient
Description
Number of patients in each group who had one or more awakening during the procedure was compared
Time Frame
one hour
Title
Bradycardia
Description
number of patients having bradycardia after induction till recovery was compared. Bradycardia is heart rate less than 60 beats per minute
Time Frame
6 hours
Title
Desaturation
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nazmeen I Sayed, MBBS,DNB
Organizational Affiliation
Lokmanya Tilak Municipal Medical College and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naina Dalvi, MBBS,MD
Organizational Affiliation
Lokmanya Tilak Municipal Medical College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
City
Mumbai
State/Province
Maharastra
ZIP/Postal Code
400022
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Dexmedetomidine Verses Propofol for Paediatric MRI Brain

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