Dexmedetomidine Verses Propofol for Paediatric MRI Brain

NCT02776189 | Completed Phase 4 DMC

• 1 other identifier: iec/30/12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Diseases

Keywords

Anaesthesia; MRI; Brain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Time for induction

  One hour

• Procedural disruptions due to awakening of the patient

  one hour

• Bradycardia

  6 hours

• Desaturation

  6 hours

Study Arms (2)

Midazolam & Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Midazolam

Midazolam & Propofol

ACTIVE COMPARATOR

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

Drug: propofol; Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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

Also known as: Dexem

Midazolam & Dexmedetomidine

propofol DRUG

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

Also known as: propoven, diprivan

Midazolam & Propofol

Midazolam DRUG

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

Also known as: Versed, Fulsed

Midazolam & Dexmedetomidine; Midazolam & Propofol

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children posted for elective MRI brain
• American society of anaesthesiologist physical status I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharashtra University of Health Sciences: lead

Study Sites (1)

Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College

Mumbai, Maharashtra, 400022, India

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Dexmedetomidine; Propofol; Midazolam

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• nazmeen I Sayed, MBBS,DNB

  Lokmanya Tilak Municipal Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Naina Dalvi, MBBS,MD

  Lokmanya Tilak Municipal Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anaesthesia, Lokmanya Tilak Municipal Medical College and Hospital

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 18, 2016
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)