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Dexmedetomidine Verses Propofol for Paediatric MRI Brain

NCT02776189 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-07-19

No results posted yet for this study

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

Interventions

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

DRUG

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

DRUG

Midazolam

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

Sponsors & Collaborators

  • Maharashtra University of Health Sciences

    lead OTHER

Principal Investigators

  • nazmeen I Sayed, MBBS,DNB · Lokmanya Tilak Municipal Medical College and Hospital

  • Naina Dalvi, MBBS,MD · Lokmanya Tilak Municipal Medical College and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02776189 on ClinicalTrials.gov