NCT03757897

The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.

The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal.

Detailed description

The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal: 1. Resting, awake state 2. During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a Bispectral index (BIS) of 60-70)

Conditions

• Cerebrospinal Fluid Pressure Increased

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2018-11-29
• Last updated: 2022-05-31

Regulatory

• FDA-regulated drug study