Dexmedetomidine for Anaesthesia therapy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA
Anaesthesia therapy+1 More
Dexmedetomidine - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.

Eligible Conditions

  • Anaesthesia therapy
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anaesthesia therapy

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 2 hours

2 hours
Brain positron emission tomography (PET) imaging signals.
Differences in electroencephalography (EEG) measures between arousal and anesthesia.
Functional magnetic resonance imaging (fMRI) signals.
Heart rate
Pulse oximetry
Respiratory physiology

Trial Safety

Safety Progress

1 of 3

Other trials for Anaesthesia therapy

Side Effects for

Dexmedetomidine
57%Clinically important hypotension
9%Clinically important bradycardia
1%Atelectasis
1%stroke
1%infection
1%Hemorrhage
0%heart failure
0%asystol
0%Pneumothorax
0%Pulmonary embolism
0%Myocardial infarction
0%Transient Ischemic attack
0%seizure
0%Hypoxemia
0%hypotension
0%Cardiogenic shock
0%re-intervention
0%Pericardial effusion
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02004613) in the Dexmedetomidine ARM group. Side effects include: Clinically important hypotension with 57%, Clinically important bradycardia with 9%, Atelectasis with 1%, stroke with 1%, infection with 1%.

Trial Design

2 Treatment Groups

Dexmedetomidine
1 of 2
Saline
1 of 2
Experimental Treatment
Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Dexmedetomidine · Has Placebo Group · Phase < 1

Dexmedetomidine
Drug
Experimental Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Saline
Drug
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours

Trial Background

Prof. Christin Y. Sander, PhD
Principal Investigator
Massachusetts General Hospital
Closest Location: Athinoula A. Martinos Center for Biomedical Imaging · Charlestown, MA
2022First Recorded Clinical Trial
1 TrialsResearching Anaesthesia therapy
2 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.