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Dexmedetomidine for Anesthesia

Phase < 1
Recruiting
Led By Christin Y Sander, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

Study Summary

This trial will use dexmedetomidine, a sedative, to study how anesthesia and artificially induced sleep affects the brain.

Eligible Conditions
  • Anesthesia
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain positron emission tomography (PET) imaging signals.
Differences in electroencephalography (EEG) measures between arousal and anesthesia.
Functional magnetic resonance imaging (fMRI) signals.
Secondary outcome measures
Heart rate
Oximetry, Pulse
Respiratory physiology

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DexmedetomidineExperimental Treatment1 Intervention
During the imaging scan subjects will receive an initial 1µg/kg bolus of dexmedetomidine up to a maximum dose of 80 µg, infused through IV over 10 minutes. After the bolus has been administered, a constant infusion of up to 0.6 µg/kg/hr (0.01 µg/kg/min) of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes).
Group II: SalinePlacebo Group1 Intervention
A saline infusion will be used as a placebo comparator for the dexmedetomidine infusion. It will be administered in the same manner and dosages as the dexmedetomidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Find a Location

Who is running the clinical trial?

Boston UniversityOTHER
454 Previous Clinical Trials
9,941,540 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,325 Total Patients Enrolled
Christin Y Sander, PhDPrincipal InvestigatorAthinoula A. Martinos Center for Biomedical Imaging
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be considered a participant in this research endeavor?

"This research study is seeking out 30 adults aged 18-45 for anaesthesia therapy. To be eligible, potential participants must have no known contraindications to MRI or PET scans."

Answered by AI

Does this experiment restrict participation to those aged 50 or younger?

"The age range for potential study enrollees is from 18 to 45 years old, as specified by the trial's eligibility requirements."

Answered by AI

Are there still available openings for participants in this research project?

"Affirmative. Clinicaltrials.gov reveals that this medical study, which was first published on April 12th 2022, is still in search of volunteers. Approximately 30 participants need to be sourced from a single clinical centre."

Answered by AI

How many participants are currently involved in this research endeavor?

"Affirmative. The clinical trial data on clinicaltrials.gov reveals that this research study is actively seeking participants and began recruitment on April 12th, 2022 with a recent update issued June 23rd of the same year. A total of 30 patients are needed from 1 medical site for enrollment in the trial."

Answered by AI
~10 spots leftby Apr 2025