Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

NCT05435560 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 2021P003426
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Brain positron emission tomography (PET) imaging signals.

  Changes in dopamine receptor availability will be quantified from brain PET images.

  2 hours

• Functional magnetic resonance imaging (fMRI) signals.

  fMRI measures of hemodynamic responses.

  2 hours

• Differences in electroencephalography (EEG) measures between arousal and anesthesia.

  Arousal states will be characterized from changes in the EEG power spectrum.

  2 hours

Secondary Outcomes (3)

• Heart rate

  2 hours

• Pulse oximetry

  2 hours

• Respiratory physiology

  2 hours

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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).

Drug: Dexmedetomidine

Saline

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

Dexmedetomidine DRUG

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).

Also known as: Precedex

Dexmedetomidine

Saline DRUG

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).

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator

Study Sites (1)

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christin Y Sander, PhD

  Athinoula A. Martinos Center for Biomedical Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irena Bass, BA

CONTACT

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

Christin Y Sander, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Christin Sander, Assistant Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: June 28, 2022
• Study Start: April 12, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)