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Comparing the efficacy and safety between Propofol And Dexmedetomidine for sedation in claustrophobic Adults undergoing Magnetic resonance imaging (PADAM)

A randomized controlled trial comparing target controlled infusion (TCI) propofol versus dexmedetomidine infusion for the treatment of anxiety in claustrophobic adults undergoing magnetic resonance imaging (MRI)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000097448
Acronym
PADAM
Enrollment
30
Registered
2016-01-29
Start date
2014-10-01
Completion date
2015-09-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Magnetic Resonant Imaging (MRI) is now widely used in clinical investigations. However, because of the design of MRI, patients are required to lie still in an enclosed tunnel like machine for some time. This poses a great challenge to patients who are claustrophobic. Most of these individuals will require sedation to reduce their anxiety in order to tolerate and complete the scan. Traditionally, benzodiazepines are the most frequently used dugs for sedation but now, more drugs with reliable and predictable pharmacological profiles are available such as propofol and dexmedetomidine. The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine as sedation to reduce the anxiety levels of claustrophobic adults undergoing MRI. This is a prospective randomized double-blinded study involving 30 adult claustrophobic patients planned for elective MRI for a medical or surgical reason in University Malaya Medical Center, Malaysia. Each group will be equal in numbers with group A receiving Propofol via Target Controlled Infusion using Schneider Model and Group B receiving Dexmedetomidine given by the attending anaesthetist. Anxiety levels will be assessed with Visual Anxiety Score (VAS) and Spielberger Straits Test Anxiety (STAI) Score taken before the drug was given and after completing the MRI scan. Adverse effects occurring during the sedation will be documented together with patient satisfaction scores before they go home.

Interventions

Recruitment steps: 1. Patients were recruited from the MRI room or registry. 2. Recruited patients were slotted into a designated time for research studies under the bio-imaging department or following their original date and time of appointment depending on which one would be earlier or convenient to the patients. 4. Patients were explained the risks and purpose of study and written informed consent was taken prior to procedure. 5. Following the trial number, patients were randomized to eithe

Recruitment steps: 1. Patients were recruited from the MRI room or registry. 2. Recruited patients were slotted into a designated time for research studies under the bio-imaging department or following their original date and time of appointment depending on which one would be earlier or convenient to the patients. 4. Patients were explained the risks and purpose of study and written informed consent was taken prior to procedure. 5. Following the trial number, patients were randomized to either: Group A: The attending anaesthetist would administer Propofol (10mg/ml) infusion, using Target Controlled Infusion (TCI) with Schnider’s pharmacokinetic model for target effect site. Drug boluses and infusions are administered according to ideal bodyweight. TCI infusion was started at a rate of 1.5 mcg/kg until the steady state was achieved then titrated with increment of 0.1mcg/kg to achieve Ramsay Sedation Score (RSS) of 3. OR Group B: The attending anaesthetist would administer Dexmedetomidine (4mcg/ml) infusion and administered according to ideal bodyweight. Loading dose of 1mcg/kg/min was given within 10 minutes and infusion was started at the rate of 0.2mcg/kg/hr and titrated by increment of 0.1mcg/kg/hr and above to achieve RSS of 3. Dosing was instituted according to the dexmedetomidine (Precedex) guidelines. It was a double-blinded study whereby both patients and the attending radiographer (the same person who would perform the Spielberg Anxiety and Visual Anxiety Scores). On the day of the re-scheduled MRI scan: 1. Patient was fasted for at least 6 hours before the scheduled scan. 2. No premed was given. 3. An Intravenous cannula (20-22G) was inserted to start 500mls of crystalloid as fluid maintenance. 4. Patient entered the scanning room for 5 minutes before being asked to answer the Spielberger Straits Traits Anxiety Score and Visual Anxiety Score to determine their anxiety levels pre-examination by the attending radiolographer. 5. Standard monitoring with non-invasive blood pressure (NIBP), heart rate, Pulse Oxymetry and electrocardiogram (ECG) was applied, monitored and recorded throughout the scan. 6. Oxygen 3L/min via nasal prong was given to the subjects. 7. A fully equipped emergency trolley and airway management was on standby in the MRI room vicinity at all times. 8. The sedative agent according to the randomized group was given intravenously and titrated until patient achieved RSS of 3. 9. Time when the drug infusion started and the time taken to achieve RSS score of 3 were recorded. 10. Once RSS of 3 was achieved, patient entered the MRI tunnel. 11. Any failed scans were recorded and reasons documented. 12. Adverse events during the scan such as i) Drop in blood pressure > 20% from baseline or requires vasopressors ii) Bradycardia <50 beats per min iii) Desaturation < 95% requiring airway and ventilation support iv) Over sedation were recorded and managed appropriately by the attending anaesthetist. After the scan: 1. Patient was monitored in the recovery bay. 2. After 5 minutes in recovery, patient was asked again to answer the Spielberger Straits Traits Anxiety Score and Visual Anxiety Score to determine their anxiety levels post examination by the same attending radiographer. 3. Vital signs and sedation scores were recorded for every half an hour until ready for discharge. 4. Any side effects or complications including hypotension, bradycardia or respiratory instability were managed accordingly. 5. The patient will be allowed home by the anaesthetist once all discharge criteria were fulfilled: v) Fully conscious vi) Hemodynamically stable vii) Able to perform physical activity without support or with minimal support. viii) No nausea or vomiting 6. Before going home, patient was asked to fill in a Patient Satisfaction Score form. 7. All data collected was analyzed statistically using SPSS.

Sponsors

Pui-San Loh
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. ASA I - II according to American Society of Anaesthesiologist guidelines. 2. Patients age 18 - 70 years old. 3. Known case of claustrophobia or history of anxiety/panic attack during an MRI study 4. Patients who were scheduled to undergo an MRI scan for a medical or surgical problem

Exclusion criteria

1. Patient related - Patient refusal BMI >30 Hypotension due to any reasons. (Systolic less than 90 mmHg) Bradycardia (heart rate less than 50 bpm) Concurrent medication which increase vagal tone or delay AV conduction (e.g.. digoxin / beta blocker) Chronic lung disease with saturation on room air <91% Obstructive sleep apnoea Requires general anaesthesia 2. Drug related - Allergic history to propofol or dexmedetomidine or related compound 3. MRI related - Any contraindications to MRI Emergency MRI Interventional procedures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026