Recruiting
Early Phase 1

Awake vs. Anesthetized

Sponsor:

Massachusetts General Hospital

Code:

NCT05435560

Conditions

Anesthesia

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Dexmedetomidine

Saline

Study Details

Brief 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.

Conditions

Anesthesia

Healthy

Study ID

NCT05435560

Start date

Apr 12, 2022

Status verified date

Jun, 2022

Completion date

Apr, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults aged 18-45.
  • No contraindications to MRI or PET scanning.

Exclusion Criteria:

  • Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
  • Pregnancy or breast feeding;
  • Current or past history of major medical, neurological, or psychiatric condition;
  • History of major head trauma;
  • Any cardiovascular disorders, including heart disorders or high blood pressure \[>155/95\];
  • Breathing problems such as severe asthma;
  • Bleeding disorder, or use of anticoagulants;
  • Bladder obstruction, urinary problems, or history of impaired elimination;
  • Known kidney or liver problems;
  • Intestinal blockage;
  • Raynaud syndrome
  • Peripheral nerve injury;
  • Diabetes;
  • Glaucoma;
  • Sleep disorder, such as sleep apnea, insomnia, or narcolepsy
  • Current use of any drugs that affect sleep
  • Current or recent use of medications (neurological or psychiatric) affecting brain function
  • Current or past history of chronic pain (assessed at discretion of PI);
  • History of allergic reactions
  • History of chronic obstructive pulmonary diseases
  • Ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement
  • Body mass index above 30
  • Current smoker
  • Lack of current health insurance coverage
  • Employed under the direct supervision of the investigators conducting the research
  • Hair in dreadlocks, twists, or braids that cannot be removed
  • Eczema on the scalp or face

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Dexmedetomidine

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).

placebo comparator: Saline

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.

Interventions

Dexmedetomidine

During the imaging scan subjects will receive an initial bolus of dexmedetomidine over 10 minutes. After the bolus has been administered, a constant infusion of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes).

Saline

During the imaging scan subjects will receive an initial bolus of saline over 10 minutes. After the bolus has been administered, a constant infusion of saline will be maintained for the remainder of the scan (about 60 minutes).

Primary outcome measure

  • Brain positron emission tomography (PET) imaging signals. [ Time Frame: 2 hours ]
  • Functional magnetic resonance imaging (fMRI) signals. [ Time Frame: 2 hours ]
  • Differences in electroencephalography (EEG) measures between arousal and anesthesia. [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Irena Bass, BA

617-726-9034ibass@mgh.harvard.edu

Christin Y Sander, PhD

617-726-9034csander@mgh.harvard.edu

Locations

Athinoula A. Martinos Center for Biomedical Imaging

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Irena Bass

617-726-9034ibass@mgh.harvard.edu

Principal Investigator:

Christin Sander, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 28, 2022

Last verified

Jun, 2022

Keywords

  • Dopamine
  • Anesthesia
  • Positron Emission Tomography
  • Magnetic Resonance Imaging
  • Electroencephalograpy
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-06-28.