Brain DiseasesPhase 4DPMPNCT02776189
Dexmedetomidine Verses Propofol for Paediatric MRI Brain
A Phase 4 study testing Dexmedetomidine, propofol and Midazolam in people with Brain Diseases, run by Maharashtra University of Health Sciences at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Brain Diseases
- What is being tested?
- Dexmedetomidine, propofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children posted for elective MRI brain
- American society of anaesthesiologist physical status I and II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
Mumbai, Maharashtra, 400022
About this study
Official title: Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient
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.
Read the 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.
- Conditions
- Brain Diseases
- Being tested
- Dexmedetomidine, propofol, Midazolam
- Keywords
- Anaesthesia, MRI, Brain
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexem
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
propofolDrug
Also called propoven, diprivan
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
MidazolamDrug
Also called Versed, Fulsed
Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: propofol; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours after procedure
Secondary outcomes (4)
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
Measured: One hour
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
Measured: one hour
Bradycardia
number of patients having bradycardia after induction till recovery was compared. Bradycardia is heart rate less than 60 beats per minute
Measured: 6 hours
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazmeen Sayed, Maharashtra University of Health Sciences
- Investigators
- nazmeen I Sayed, MBBS,DNB, Principal investigator, Lokmanya Tilak Municipal Medical College and HospitalNaina Dalvi, MBBS,MD, Principal investigator, Lokmanya Tilak Municipal Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776189
- Sponsor's protocol ID
- iec/30/12
- Acronym
- DPMP
- Status last verified
- Jul 2016
- First submitted
- 11 May 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient
- ClinicalTrials.gov ID
- NCT02776189
- Acronym / sponsor ID
- DPMP / iec/30/12
- Conditions
- Brain Diseases
- Keywords
- Anaesthesia, MRI, Brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam & Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: MidazolamIntra 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 |
| Midazolam & Propofol | Active comparator | Drug: propofol, Drug: MidazolamIntra 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 |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children posted for elective MRI brain
- American society of anaesthesiologist physical status I and II
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexemintravenous 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 | Midazolam & Dexmedetomidine |
| propofolAlso: propoven, diprivanintravenous 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 & Propofol |
| MidazolamAlso: Versed, FulsedIntra nasal midazolam 0.2 mg per kg body weight before intravenous canulation | Drug | Midazolam & Dexmedetomidine, Midazolam & Propofol |
Primary outcome
Recovery time
Time frame: 4 hours after procedure
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 secondary outcomes
Time for induction
Time frame: One hour
Procedural disruptions due to awakening of the patient
Time frame: one hour
Bradycardia
Time frame: 6 hours
Desaturation
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nazmeen I Sayed, MBBS,DNB principal investigator
Lokmanya Tilak Municipal Medical College and Hospital
Naina Dalvi, MBBS,MD principal investigator
Lokmanya Tilak Municipal Medical College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, propofol and Midazolam in people with Brain Diseases, run by Maharashtra University of Health Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: 4 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.