Clinical trial NCT02776189: Dexmedetomidine Verses Propofol for Paediatric MRI Brain
Official title: Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Diseases
Keywords: Anaesthesia
MRI
Brain
Lead sponsor: Maharashtra University of Health Sciences
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery time
timeFrame: 4 hours after procedure
Secondary outcomes:
measure: Time for induction
timeFrame: One hour
measure: Procedural disruptions due to awakening of the patient
timeFrame: one hour
measure: Bradycardia
timeFrame: 6 hours
measure: Desaturation
timeFrame: 6 hours
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
state: Maharastra
Study officials:
affiliation: Lokmanya Tilak Municipal Medical College and Hospital
name: nazmeen I Sayed, MBBS,DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Lokmanya Tilak Municipal Medical College and Hospital
name: Naina Dalvi, MBBS,MD
role: PRINCIPAL_INVESTIGATOR
References: