RECRUITING

REcovery from DEXmedetomidine-induced Unconsciousness

Conditions

Anesthesia Healthy Consciousness, Level Altered Dexmedetomidine EEG Transcranial magnetic stimulation Cognition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.

Official Title

REcovery from DEXmedetomidine-induced Unconsciousness

Quick Facts

Study Start:2024-10-18

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06003127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Between the ages of 18 to 65 * Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2 * Non-smoker * No history of taking stimulants or substance abuse * For women: either use of hormonal contraception, or \> 45 years old and last menstrual period \> 12 months ago in the absence of any contraceptives. * American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1) * Fluent in English (sufficient to communicate with the study team and understand the consent form)	* Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder * Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder) * Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death * Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea * Gastrointestinal: esophageal reflux, hiatal hernia, ulcer * Hepatic: hepatitis, jaundice, ascites * Renal: acute or chronic severe renal insufficiency * Reproductive: pregnancy, breast-feeding * Endocrine: diabetes, thyroid disease, adrenal gland disease * Hematologic: blood dyscrasias, anemia, coagulopathies * Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia * Medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception * Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate

Inclusion Criteria

Exclusion Criteria

* Between the ages of 18 to 65
* Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2
* Non-smoker
* No history of taking stimulants or substance abuse
* For women: either use of hormonal contraception, or \> 45 years old and last menstrual period \> 12 months ago in the absence of any contraceptives.
* American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)
* Fluent in English (sufficient to communicate with the study team and understand the consent form)

* Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder
* Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)
* Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death
* Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea
* Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
* Hepatic: hepatitis, jaundice, ascites
* Renal: acute or chronic severe renal insufficiency
* Reproductive: pregnancy, breast-feeding
* Endocrine: diabetes, thyroid disease, adrenal gland disease
* Hematologic: blood dyscrasias, anemia, coagulopathies
* Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
* Medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception
* Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate

Contacts and Locations

Study Contact

Ken Solt, MD

CONTACT

1-617-726-4359

ksolt@mgh.harvard.edu

David Schreier, MD, PhD

CONTACT

dschreier@mgh.harvard.edu

Principal Investigator

Ken Solt, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Ken Solt, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-18

Study Completion Date2025-05

Study Record Updates

Study Start Date2024-10-18

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

Dexmedetomidine
EEG
Transcranial magnetic stimulation
Cognition

Additional Relevant MeSH Terms

Anesthesia
Healthy
Consciousness, Level Altered