Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI
Phase: PHASE2
Conditions: Airway Remodeling
Sponsor: Milton S. Hershey Medical Center

IRB: 35165
Date: 10/12/2015
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Comparison of Changes in Upper Airway Dimensions 
with Dexmedetomidine and Propofol in children 
undergoing MRI
Dr Uma R Parekh, MBBS, DNB, FRCA, FFARCSI
Approval: 9/26/2018

IRB: 35165
Date: 10/12/2015
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Table of Contents
Sections
1.0
Introduction
2.0
Objectives
3.0
Study Design and Methods
4.0
Inclusion and Exclusion Criteria
5.0
Recruitment and Consent Process
6.0
Study Procedures
7.0
Risks and Discomforts
8.0
Benefits
9.0
Reporting of Adverse Events and Unanticipated Problems Involving Risks to 
Participants or Others
10.0
Study Withdrawal/Discontinuation
11.0
Statistical Analysis of the Study
12.0
Privacy and Confidentiality Considerations
13.0
Data and Safety Monitoring Plan
14.0
Compensation
15.0
Drugs, Biologics, or Devices
16.0
Records and Study Monitoring
17.0
Facilities
18.0
References
Appendices
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1.0
Introduction
Propofol is being successfully used to sedate children undergoing MRI (Magnetic 
Resonance Imaging) (1). Dexmdetomidine has also been shown to provide adequate 
sedation without affecting cardiovascular and respiratory stability (2). There are studies 
comparing the sedative, hemodynamic and respiratory effects of dexmedetomidine and 
propofol in children undergoing MRI, demonstrating that both drugs provide adequate 
sedation in most  children although, propofol provided more rapid anesthetic 
induction, recovery and discharge. Dexmedetomidine better preserved MAP (mean 
arterial pressure) and RR (respiratory rate) and was not associated with desaturations 
(3). Studies in spontaneously breathing children undergoing MRI have also shown that 
increasing depth of propofol sedation resulted in a reduction in upper airway caliber 
(4). Therefore in children with airway compromise, dexmedetomidine may be a better 
option for sedation. This is supported by a study which demonstrated that MRI sleep 
studies were completed without artificial airways in a larger proportion of children 
with OSA (obstructive sleep apnea) receiving dexmedetomidine than with propofol (5).  
There are no studies, comparing airway dimensions in children sedated with propofol 
and dexmedetomidine.
2.0
Objectives
The objective of this study is to compare the changes in upper airway configuration at 
the level of soft palate, base of tongue and tip of the epiglottis in children sedated with 
dexmedetomidine and propofol while undergoing diagnostic MRI.
We hypothesize that the upper airway caliber will be smaller in children receiving 
propofol than with dexmedetomidine.
3.0
Study Design and Method
Single blind randomized controlled trial. (Two treatment parallel study)
A total of 40 Study subjects will be placed into two groups of 20 each. Patients in Group 
P will be sedated with propofol while those in group D will receive dexmedetomidine 
(open label). The person analyzing the images of the airway and taking measurements 
will not be aware of the sedation agent used on that subject.  The person collecting and 
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analyzing the data will be aware of which drug is being administered. Patients will be 
randomly assigned, either propofol or dexmedetomidine.  There will be two groups, 
group P and group D, 20 in each group. Group P will receive propofol and group D, 
dexmedetomidine. The physician analyzing the data will be aware of which drug is 
being administered. Patient will be randomly assigned, either propofol or 
dexmedetomidine.  Randomization will be by a computer generated randomization 
table.
4.0    Inclusion and Exclusion Criteria
Inclusion criteria
- Children undergoing MRI brain
- Age 3 – 6 yrs inclusive
- ASA I – II
Exclusion criteria
- OSA
- Pathology of upper airway
-  Severe Craniofacial anomalies that would affect airway management
- Severe Gastroesophageal reflux
- Increased intracranial pressure
- Body weight of 20% more than ideal
- Contraindication to the use of either drug
5.0     Recruitment and Consent Process
The parents of children scheduled for a diagnostic MRI of the head and neck will be 
approached to participate in this study
Participants will be recruited on the day they arrive for MRI by informed parental 
consent as per the inclusion and exclusion criteria. 
The consent for the study will be obtained by a member of the research team from 
either the parent or the legal guardian on the day of the procedure. They will not be 
involved in obtaining consent for the procedure.
6.0     Study Procedures 
Children arriving for MRI will have a preoperative evaluation performed including 
history and physical examination as for any child scheduled to have sedation for MRI. 
Those children meeting the inclusion criteria, after having obtained informed parental 
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consent, will be enrolled into the study. They will be randomly assigned, as described 
above, to receive either propofol or dexmedetomidine. 
Sequence of study events will be as follows: 
No premedication will be given.
 All children will be induced with 70% N2O and 6% sevoflurane in oxygen and an 
intravenous cannula will be inserted. N2O and sevoflurane will be turned off and drugs 
will be administered as follows. Glycopyrrolate 10mcg/kg will be administered IV.
Administer propofol bolus at 3mg/kg, or dexmedetomidine at 2 mcg/kg over 10min 
followed by an infusion of propofol at 240 mcg/kg/min, or dexmedetomidine at 
3mcg/kg/hr respectively. In the propofol group, if the patient is unable to lay still at 
this dose, a further bolus of 1mg/kg will be administered to a total bolus dose of 
5mg/kg. If the patient requires more than this dose, he/she will be excluded from the 
study.
The patient will breathe spontaneously throughout the study while O2 is administered 
(3l/min) via a nasal cannula.
A best attempt will be made to position the child’s head in the neutral position with a 
folded sheet beneath the neck or shoulders.
When immobile for 5 min and endtidal sevoflurane is 0%, airway images will be 
obtained as described later (T1).
Throughout the procedure, arterial oxygen saturation, exhaled carbon dioxide tension, 
respiratory rate, heart rate and arterial blood pressure will be monitored continuously 
and recorded at 5-min intervals during the study period by the anesthesiologist.
The infusions will be discontinued at the end of the scheduled imaging sequence and 
the patient will be transferred to the recovery area.
Images will be acquired in inspiration and expiration at the level of:
1. the soft palate 
2. base of the tongue 
3. tip of the epiglottis  
 A routine axial T2 weighted sequence will be employed to obtain images.  At each 
anatomic level, 8 measurements will be obtained and values will be averaged. No 
attempt will be made to obtain images at a certain point in the respiratory cycle. These 
images will be in addition to routine sequences obtained for the clinical study.  Each 
slice will take approximately 1 second. We are estimating therefore, approximately 18 
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extra seconds of imaging time added to the study. Please note that MRI has no radiation 
exposure.
After image acquisition following will be calculated at each level by the radiologist on 
the radiology PACS workstation.
1. cross sectional area (CSA)
2. anteroposterior (AP) diameter
3. transverse (Tr) diameter
At each anatomic level, measurements will be obtained 8 times and average values will 
be calculated.
In each child transverse and anteroposterior dimensions will also be measured at the 
level of the vocal cords and the cricoid ring in the axial scan. An additional level may be 
measured between the vocal cords and the cricoid ring i.e. sub-vocal cord level.
The study should be completed in 18 months.
Data collection:
1. demographic data, age sex, weight, height, race
2. clinical parameters: heart rate, blood pressure, respiratory rate, SpO2(by pulse        
    oximetry) every 5 minutes.
3. temperature of the subject before and after the study
4. airway dimensions for each drug 5. emergence agitation score in recovery room at 5, 
10, 15 and 30 mins
6. sedation score in recovery at 15,30 and 60 mins
7. recovery time (time from discontinuation of sedation to readiness to discharge)
7.0    Risks and Discomforts
Propofol is a substituted isopropylphenol administered intravenously as 1% solution to 
induce and maintain anesthesia. Studies have shown that anesthesiologist-administered 
propofol TIVA with oxygenation via nasal prongs in spontaneously breathing children 
is a reliable technique with good preservation of upper airway patency and rapid 
induction and recovery rates. At Hershey Medical Center, this technique is utilized in 
most children presenting for MRI. 
Hypotension and bradycardia are observed occasionally when propofol is used as a 
single drug to achieve sedation (2, 6,). The decrease in MAP and HR reported after 
propofol induction is 15%-31% and 17%-24% respectively (7). In our study, if the MAP 
decreases >20% from the base line, a fluid bolus of 10mls/kg of lactated Ringer’s 
solution will be administered. All patients will receive 10mcg/kg of glycopyrrolate after 
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placement of IV line for its antisialogogue effect. This should also prevent any 
bradycardia associated with propofol and dexmedetomidine.  5.5% of complications of 
sedation in children are respiratory events. Respiratory complications, though not 
consistent, reported with propofol are ventilatory depression, suppression of 
pharyngeal and laryngeal reflexes and transient respiratory arrest. (7, 8, 9,). This may be 
more pronounced in children with existing respiratory obstruction. We have chosen to 
exclude this group. Inadequate sedation is the most common adverse event (5%-15%) 
resulting in failure (3.7%) of MRI procedures. A study by Usher et al (1) demonstrated 
that movement during imaging was more likely at lower infusion rates (mean 
175mcg/kg/min) than when mean infusion rate was 193mcg/kg/min (range 150-250 
mcg/kg/min). In our experience at Hershey Medical Center, we frequently have to 
increase the infusion to 250mcg/kg/min to prevent movement during the scan. 
Therefore we have chosen to image the airway at this higher infusion rate, and then 
decrease to 200mcg/kg/min for the rest of the imaging. Other problems seen with 
propofol are burning, stinging or pain at the injection site. Some of the rare risks of 
propofol include irregular heart rate, rash, itching, agitation, increased blood pressure 
and increased heart rate.
Dexmedetomidine is a highly selective alpha-2 adrenoceptor agonist that has sedative 
and analgesic effects. Respiratory complications, reported with large and rapid (2mins) 
initial loading doses of dexmedetomidine include irregular respiration, respiratory 
depression and transient respiratory arrest. (9). Studies have also shown when bolus 
doses were administered over 10 mins; saturations were maintained at 95% or higher 
(5). We have chosen to administer the bolus over 10 mins. Data obtained from any 
patient unable to maintain a patent airway during the study will not be analyzed. 
Airway obstruction will be managed by insertion of either an oral or a nasopharyngeal 
airway. If that fails, a laryngeal mask airway will be inserted to maintain a patent 
airway. The hemodynamic effects of dexmdetomidine in healthy adults is biphasic, 
with an initial increase in systolic blood pressure and a reflex decrease in heart rate 
followed by stabilization of heart rate and blood pressure below baseline (12). In a 
study by Mason et al(16), although the incidence of bradycardia during 
dexmedetomidine sedation was 16%, the majority of patients had heart rate values 
within 20% of the age-adjusted values of ‘awake’ children. During these bradycardic 
episodes, the MAP of these patients was always within 20% of age-adjusted values (16).  
Review of 747 patients, comparing three different dosage protocols of 
dexmedetomidine, demonstrated dosages required to successfully complete MRI scans 
are significantly greater than dosages approved by the Food and Drug Administration. 
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In their study, at a bolus dose of 3mcg/kg and infusion of 2mcg/kg/hr, 2.4% of patients 
required adjuvant sedation as compared to 7.4% in the lower dose group. In a study 
comparing dexmedetomidine and propofol for MRI sleep studies in children (5), the 
median bolus dose of dexmedetomidine was 2mcg/kg and the median infusion rate 
was 2mcg/kg/hr. We have chosen the proposed dexmedetomidine dosage for our 
study from these findings. If the upper airway cannot be satisfactorily imaged at this 
dose of dexmedetomidine, propofol will be used as the rescue drug and the subject 
withdrawn from the study.
Since dexmedetomidine has a longer half-life than propofol, children receiving 
dexmedetomidine will be sedated longer after the procedure than with propofol. Other 
rare risks for dexmedetomidine include nausea, dry mouth, wheezing and irregular 
heart rate. 
8.0    Benefits
When compared to dexmedetomidine, propofol sedation is associated with more 
desaturations and decreases in RR.  The need for artificial airway support is 
significantly more when children are sedated with propofol (35%) than with 
dexmedetomidine (12%) (17). We hypothesize that the relaxant effects of 
dexmedetomidine on upper airway muscle tone are less than those with propofol for 
any given level of anesthesia. The effects of propofol and dexmedetomidine at high and 
low doses have been studied individually, however, there are no studies comparing the 
effect of the two drugs on upper airway dimensions. This study will shed light on this. 
Although there are no direct benefits to the patients in this study, the data obtained will 
be useful when we have to encounter patients with compromised airways.
9.0    Reporting of Adverse Events and Unanticipated Problems Involving Risks 
   to Participants or Others
The PI will be responsible for the identification and reporting of any adverse events 
associated with the study.  All reportable AE’s and unanticipated problems will be 
reported to the IRB, per IRB policy.
10.0   Study Withdrawal/Discontinuation
If a parent chooses to withdraw consent or is discontinued from the study; the 
researchers will no longer use or share any medical information about the patient for this 
research study, except when the law allows them to do so.  The researchers will be unable 
to take back anything they have already done or any information they have already 
shared with the parent’s permission.  The investigators may continue using and sharing 
the information obtained prior to the patient’s withdrawal if it is necessary for the 
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soundness of the overall research.  The investigators will keep records of the care that was 
provided as long as the law requires.
11.0   Statistical Analysis of the Study
Study participants will be recruited among those presenting for MRI under sedation 
consistent with inclusion and exclusion criteria. Participants will be randomized to 
either receive propofol (Group P) or dexmedetomidine (Group D) for sedation. 
Primary Outcome
To measure and compare the cross-sectional area (CSA) of the upper airway at the level 
of soft palate, base of the tongue and epiglottis in both groups of children at high doses 
of propofol and dexmedetomidine. Secondary Outcomes
 To measure and compare the 
•
anteroposterior (AP) diameter 
•
transverse (Tr) diameter
of the upper airway at the three levels in both groups of children. To measure and 
compare AP and Tr dimensions at the level of the vocal cords and cricoid ring and may 
be an additional level between the vocal cords and the cricoid ring.
Statistical Power and sample size
For the estimation of sample size, we assumed an effect size similar to that reported in 
previous studies evaluating the airway dimensional changes occurring with propofol 
sedation. We assume that with dexmedetomidine, there will be minimal or no 
significant changes in airway dimensions. For a two-tailed α of 0.05 and a β of 0.2 
(power = 80%), we estimated that 15 patients in each group would be required to 
demonstrate a 25% difference in CSA with high doses of propofol and 
dexmedetomidine infusions. Assuming dropouts due to incomplete data, a total of 40 
patients, 20 in each group will be enrolled in the study.
Statistical Methods
Statistical Analysis: Continuous data will be presented as mean ± SD. Two way 
repeated measures analysis of variance will be used to compare upper airway CSA and 
dimensions. P < 0.05 will be considered statistically significant.
12.0   Privacy and Confidentiality Considerations
The principal investigator will be solely responsible for data collection and verification, 
and review of cumulative adverse events. Confidentiality will be protected by utilizing 
a code number as the only identifier for each subject and list will be kept under lock and 
key with access limited to the PI and  co-investigator, Dr. Hulse, and the clinical 
research nurse.
13.0   Data and Safety Monitoring Plan
This study involves low risk to subjects as it involves administering propofol to one 
group of patients for sedation of children undergoing MRI, which is, our routine 
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practice. The safety of dexmedetomidine for sedation in children is well documented in 
literature as mentioned earlier. 
Risks associated with propofol include respiratory depression, transient apnea, 
hypotension, bradycardia, pain on injection. Very rare risks include rash, itching, and 
agitation. Risks associated with dexmedetomidine include irregular respiration, 
respiratory depression, hypertension, hypotension, bradycardia and prolonged 
sedation. Very rare risks associated with dexmedetomidine include nausea, dry mouth, 
and wheezing. Risks associated with propofol include respiratory depression, transient 
apnea, hypotension, bradycardia, pain on injection. Very rare risks include rash, itching, 
and agitation. 
The total time to scan the airways will be less than 5 minutes. Therefore there is 
minimal risk of prolonging the total scan time.
Oversight for the conduct of the study will be provided by the PI, Dr. Uma Parekh and 
the clinical research nurse assigned to the study. They will ensure that all eligibility 
criteria and consent requirements are met prior to a subject’s participation on study and 
that all study procedures and adverse event reporting occur according to the IRB 
approved protocol.
All data forms and study specific information will be kept in locked file cabinets and 
password protected database with access limited to the PI and clinical research nurse. 
Any presentation or publication of the data will be done in aggregate fashion without 
identifiers.
All adverse events will be documented on study specific case report forms and entered 
into a computer-based log. Risks associated with propofol include respiratory 
depression, transient apnea, hypotension, bradycardia, pain on injection. Very rare risks 
include rash, itching, and agitation. Risks associated with dexmedetomidine include 
irregular respiration, respiratory depression, hypertension, hypotension, bradycardia 
and prolonged sedation. Very rare risks associated with dexmedetomidine include 
nausea, dry mouth, and wheezing. Risks associated with propofol include respiratory 
depression, transient apnea, hypotension, bradycardia, pain on injection. Very rare risks 
include rash, itching, and agitation. 
Intravenous access for the study participants will be obtained using oxygen and nitrous 
oxide. Nitrous oxide will then be switched off and the study drug administered. 
Nitrous oxide is a good analgesic and will be helpful to prevent the pain from propofol 
which will be given as a slow bolus. The commonest irregularity in heart rate seen is 
bradycardia. Glycopyrrolate is going to be administered to all patients and will prevent 
the bradycardia in both groups. Hypotension (< 20% from baseline) will be treated with 
a 10mlkg fluid bolus with crystalloids. All anesthetic agents are respiratory depressants. 
Respiratory depression will be treated if it affects oxygenation (SpO2 < 95%) as 
monitored by pulse oximetry. A nasopharyngeal airway will be inserted first. If it fails 
to improve oxygenation, a laryngeal mask airway will be used. If an airway 
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intervention is required, the participant will be excluded from the study. If the child 
fails to be sedated with the maximum doses mentioned in the protocol, the participants 
will be excluded from the study. The other risks are extremely rare.
The PI and clinical research nurse will review all adverse events regularly and report 
any issues requiring modification of the study or alteration of the risk: benefit ratio to 
the IRB immediately. A summary of adverse events, study progress and protocol 
modifications will be included for IRB review in the continuing review report.
 Cumulative adverse events and study progress will be reported to the IRB at the time 
of continuing review.
14.0   Compensation
There are no payments or compensation to participants.
15.0   Drugs
Propofol and dexmedetomidine will be obtained from the pharmacy. The amount of 
drug infused will be recorded in the anesthetic record. The unused drugs will be 
disposed in accordance with the departmental policies by Dr Parekh/Dalal.
Propofol is not recommended for induction of anesthesia in children <3 years or for 
maintenance of anesthesia in infants <2 months of age, and not recommended for 
monitored anesthesia care sedation in children. However there are enough studies as 
referenced throughout the protocol regarding the safety of its use in this age group. It is 
regularly used at Hershey Medical center as well as most children’s hospitals around 
the world for sedating children undergoing MRI.
Dexmedetomodine is FDA approved in age’s ≥18 years. Again there are many studies 
demonstrating use of dexmedetomidine in all age groups. (2, 14)
16.0   Records and Study Monitoring
Oversight for the conduct and monitoring of the study will be provided by the PI, 
Dr. Uma Parekh/Dr. Dalal / Research coordinator (Chris Mulvey) will be solely 
responsible for the data collection and verification.
17.0   Facilities
All studies will be conducted in MRI suite and its recovery area at PSMSHMC.
18.0   References
1.   Usher AG et al. Propofol total intravenous anesthesia for MRI in children. Pediatr 
      Anaesth 2005; 15:23-28.
2.   Koroglu A et al. Sedative, hemodynamic and respiratory effects of  
      dexmedetomidine in children undergoing MRI examination: preliminary results. Br 
      J Anaesth 2005; 94:821-4 
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3.   Koroglu et al. A Comparison of the sedative, hemodynamic, and respiratory effects
      of Dexmedetomidine and propofol in children undergoing MRI. Anesth Analg 2006;
      103:63-7.
4.   Evans et al. Effect of increasing depth of propofol anesthesia on upper airway 
      configuration in children Anesthesiology 2003; 99:596-602
5.   Mahmood M et al. A comparison of dexmedetomidine with propofol for MRI 
      sleeps studies in children. Anesth Analg 2009; 109:745-53
6.  Arun CS. New intravenous agents. Br J Anaesth 1999; 83:29-41
      7.  Tramer MR et al. Propofol and bradycardia: causation, frequency and severity 
      Br. J Anaesth 1997; 78:642-51
 8.  Dial S et al. Pediatric sedation for procedures tirated to desired degree of immobility     
      result in unpredictable depth of sedation. Pediatr Emerg Care 2001; 17:414-20  
 9.  Frankviller DD et al. The dose of propofol required to prevent children from moving 
     during MRI. Anesthesiology 1993; 79:953-8
10. Ebert TJ et al. The effect of increasing plasma concentrations of dexmedetomidine in 
      humans. Anesthesiology 2000; 93:382-94
11. Bhana KNL, MCClellan GJ, McClellan KJ. Dexmedetomidine. Drugs 2000; 59:263-
 12. Kallio A et al. Effects of dexmedetomidine, a sedative alpha2-adrenoceptor agonist, 
      on hemodynamic control mechanisms. Clin Pharmacol Ther 1989; 49:33-42
13. Bloor BC et al. Effects of intravenous dexmedetomidine in humans. II. 
      Hemodynamic changes. Anesthesiology 1992; 77:1134-42.
14. Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric 
      anesthesiology. Pediatr Crit Care Med 2007; 8:115-31.
15. Mason KP et al. High dose dexmedetomidine as the sole sedative for pediatric MRI.
      Pediatr Anes 2008; 18:403-11.
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Appendices
Appendix A
ASA Physical Status Classification System
ASA Physical Status 1 - A normal healthy patient
ASA Physical Status 2 - A patient with mild systemic disease
ASA Physical Status 3 - A patient with severe systemic disease
ASA Physical Status 4 - A patient with severe systemic disease that is a constant threat 
to life
ASA Physical Status 5 - A moribund patient who is not expected to survive without the 
operation
ASA Physical Status 6 - A declared brain-dead patient whose organs are being 
removed for donor purpo
Appendix B
The following measurements will be made for each drug at both at  high doses at the 
following levels
Soft palate
CSA (mm2)  1
                       2
                       3
Mean CSA   
AP (mm)       1
                       2
                       3
Mean AP
Tr(mm)          1
                        2
                        3
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Mean Tr
Base of tongue 
CSA (mm2)    1            
                         2            
                         3
Mean CSA
AP (mm)         1
                         2
                         3
Mean AP
Tr (mm)          1
                         2
                         3
Mean Tr
Tip of epiglottis
CSA (mm2)     1
                          2
                          3
Mean CSA
AP (mm)         1
                         2
                         3
Mean  AP
Tr (mm)          1
                         2
                         3
Mean Tr
Appendix C
Scoring system for emergence delirium (ED)
1  Sleeping
2  Awake, calm
3  Irritable, crying
4  Inconsolable crying
5  Severe restlessness, disorientation
Appendix D
University of Michigan Sedation Scale
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0  Awake and alert
1  Minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or
   sound
2  Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation 
   or a simple verbal command
3  Deeply sedated: deep sleep, arousable only with significant physical stimulation
4  Unarousable
On arrival 
15 min
30 min
60 minutes
ED score
Sedation score
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