REcovery From DEXmedetomidine-induced Unconsciousness

Healthy Clinical Trial

— REDEX  

Official title:

REcovery From DEXmedetomidine-induced Unconsciousness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06003127
• Other study ID #: 2023P001821
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Ken Solt, MD
• Phone: 1-617-726-4359
• Email: ksolt[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 to 45

• 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: use of hormonal contraception

• 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)

Exclusion Criteria:

• 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

Potential participants will not be enrolled in our study if they fail to pass a drug test that screens for the following: Cocaine (COC), d-Amphetamine (AMP), d-Methamphetamine (Mamp), Tetrahydrocannabinol (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazepines (BZO), Oxycodone (OXY)

Related Conditions & MeSH terms

• Anesthesia
• Consciousness Disorders
• Consciousness, Level Altered
• Healthy
• Unconsciousness

Intervention

Device:
• Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation and measurement of related evoked potentials in the EEG.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

References & Publications (2)

Kato R, Zhang ER, Mallari OG, Moody OA, Vincent KF, Melonakos ED, Siegmann MJ, Nehs CJ, Houle TT, Akeju O, Solt K. D-Amphetamine Rapidly Reverses Dexmedetomidine-Induced Unconsciousness in Rats. Front Pharmacol. 2021 May 18;12:668285. doi: 10.3389/fphar.2021.668285. eCollection 2021. — View Citation

Vincent KF, Mallari OG, Dillon EJ, Stewart VG, Cho AJ, Dong Y, Edlow AG, Ichinose F, Xie Z, Solt K. Oestrous cycle affects emergence from anaesthesia with dexmedetomidine, but not propofol, isoflurane, or sevoflurane, in female rats. Br J Anaesth. 2023 Jul;131(1):67-78. doi: 10.1016/j.bja.2023.03.025. Epub 2023 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return of responsiveness	The time to return of responsiveness will be measured in minutes and from the moment of dexmedetomidine discontinuation to the return of hand squeezing (five times in a row) in response to auditory stimulation.	Up to 120 minutes