Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

NCT ID: NCT05435560

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2023-04-30

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.

Detailed Description

A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a normal saline infusion, as a control. The order of these two scans will be randomized, and the study design is open label (ie subjects and investigators know which session will be the control scan and which one will be the sedative scan). Investigators hope that by comparing the results of the sedative and control scans, the different neuromodulatory states involved in the transition from wakefulness to medically induced vs naturally occurring sleep can be better understood.

Conditions

Anesthesia; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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).

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: 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).

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christin Y. Sander, PhD

Dr Christin Sander, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christin Y Sander, PhD

Role: PRINCIPAL_INVESTIGATOR

Athinoula A. Martinos Center for Biomedical Imaging

Locations

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Irena Bass, BA

Role: CONTACT

ibass@mgh.harvard.edu

617-726-9034

Christin Y Sander, PhD

Role: CONTACT

csander@mgh.harvard.edu

617-726-9034

Facility Contacts

Irena Bass

Role: primary

ibass@mgh.harvard.edu

617-726-9034

Other Identifiers

2021P003426

Identifier Type: -

Identifier Source: org_study_id